Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Secondary Acute Myeloid Leukemia
Conditions
Brief summary
This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.
Detailed description
PRIMARY OBJECTIVES: I. To test whether outcomes of patients of age 60 or older with previously untreated non-M3 acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to warrant phase III investigation. II. To estimate the frequency and severity of toxicities of this regimen in the good- and poor-risk groups of patients. III. To investigate in a preliminary manner the disease-free survival of patients who achieve complete remission and receive post-remission therapy on this study. IV. To investigate in a preliminary manner the cytogenetic response rates of patients treated with this regimen. V. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter and global methylation changes, and multidrug resistance on overall survival and response to azacitidine plus gemtuzumab ozogamicin therapy. OUTLINE: Patients are stratified according to risk status (good \[60-69 years of age OR Zubrod performance status \[PS\] 0-1\] vs poor \[\>= 70 years of age AND Zubrod PS 2-3\]). REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients with residual leukemia (blast count \>= 5%) receive a second course of induction therapy beginning between days 15-29. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy (with azacitidine given SC only). MAINTENANCE THERAPY: Patients receive azacitidine SC on days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic studies at baseline, remission, and relapse or progression (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA. After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Interventions
Given IV or SC during induction; given SC during consolidation and maintenance
Given IV
Sponsors
Study design
Eligibility
Inclusion criteria
* Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible * Zubrod performance status 0-3 * No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin * No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted * Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria: * No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support * Prior cytarabine allowed if dose \< 100 mg/m\^2/day * Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed * No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin * At least 30 days since prior therapy for MDS and recovered * Bilirubin =\< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML * Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed * Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =\< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML * Serum creatinine =\< 1.5 x IULN * Left ventricle ejection fraction (LVEF) \>= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days * Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory * Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking * No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture * Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method * Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration * HIV-positive patients must meet the following criteria: * No history of acquired immunodeficiency syndrome (AIDS)-defining events * CD4 cells \>= 500/mm\^3 * Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on cART or \< 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study * No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base * Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration * Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) \>= 1,000/mcL and platelets \>= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration * Patients must have serum creatinine =\< 1.5 x IULN and SGOT or SGPT =\< 1.5 x IULN within 28 days before registration * Patients must have recovered to =\< Grade 2 from any induction cycle non-hematologic toxicities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | Up to 60 days | Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL. |
| 30-Day Survival | 30 days | Patients surviving more than 30 days after study registration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 5 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Relapse-free Survival | Up to 5 years | Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease. |
Countries
United States
Contacts
SWOG Cancer Research Network
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | 79 |
| Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | 54 |
| Total | 133 |
Baseline characteristics
| Characteristic | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
|---|---|---|---|
| Age, Continuous | 76 years | 73.4 years | 71.2 years |
| Hispanic No | 50 participants | 114 participants | 64 participants |
| Hispanic Unknown | 3 participants | 15 participants | 12 participants |
| Hispanic Yes | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 5 participants | 1 participants |
| Race/Ethnicity, Customized White | 50 participants | 127 participants | 77 participants |
| Sex: Female, Male Female | 21 Participants | 51 Participants | 30 Participants |
| Sex: Female, Male Male | 33 Participants | 82 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| other Total, other adverse events | 130 / 133 | 32 / 32 | 26 / 27 |
| serious Total, serious adverse events | 55 / 133 | 1 / 32 | 3 / 27 |
Outcome results
30-Day Survival
Patients surviving more than 30 days after study registration
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remission Induction Chemotherapy | 30-Day Survival | 92 percentage of participants |
| Consolidation Therapy | 30-Day Survival | 87 percentage of participants |
Complete Response
Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Time frame: Up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remission Induction Chemotherapy | Complete Response | 44 percentage of participants |
| Consolidation Therapy | Complete Response | 35 percentage of participants |
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 5 years
Population: Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 10 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-cardiopulmonary disease | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 73 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 4 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Blood | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Stomach | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-Chest Pain | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Upper GI NOS | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - SVT tachycardia | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-platelets and red blood cells | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 3 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hepatobiliary/Pancreas-venoocclusive disease | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin I (cTnI) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 6 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 85 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 4 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac-ischemia/infarction | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 8 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 16 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Kidney | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 4 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 3 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Conduction abnormality NOS | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - Atrial fibrillation | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 3 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Constipation | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sudden death | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 85 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 4 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Disease progression NOS | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 6 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Multi-organ failure | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death not associated with CTCAE term - Death NOS | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary/Upper Respiratory-pulmonary edema | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 23 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Liver dysfunction/failure (clinical) | 0 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 2 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 80 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Edema: limb | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Atrial fibrilation | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-bacteremia | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 18 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 5 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Aspirgillosis | 1 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 50 Participants |
| Remission Induction Chemotherapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Atrial fibrilation | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-cardiopulmonary disease | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-Chest Pain | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin I (cTnI) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac-ischemia/infarction | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Conduction abnormality NOS | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Disease progression NOS | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Multi-organ failure | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death not associated with CTCAE term - Death NOS | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Edema: limb | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 3 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Stomach | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Upper GI NOS | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-platelets and red blood cells | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hepatobiliary/Pancreas-venoocclusive disease | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Kidney | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Blood | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Aspirgillosis | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-bacteremia | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 18 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Liver dysfunction/failure (clinical) | 1 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 21 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 12 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary/Upper Respiratory-pulmonary edema | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - SVT tachycardia | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sudden death | 0 Participants |
| Consolidation Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Carbon monoxide diffusion capacity (DL(co)) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Aspirgillosis | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Edema: limb | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-bacteremia | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 2 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 6 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary/Upper Respiratory-pulmonary edema | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Liver dysfunction/failure (clinical) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death not associated with CTCAE term - Death NOS | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 1 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Multi-organ failure | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Death - Disease progression NOS | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 10 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Cardiac/heart | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Conduction abnormality NOS | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac-ischemia/infarction | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sudden death | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Kidney | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin I (cTnI) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - SVT tachycardia | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hepatobiliary/Pancreas-venoocclusive disease | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 3 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-platelets and red blood cells | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-Chest Pain | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Upper GI NOS | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac General-cardiopulmonary disease | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Stomach | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Atrial fibrilation | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 1 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Blood | 0 Participants |
| Maintenance Therapy | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 2 Participants |
Relapse-free Survival
Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
Time frame: Up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remission Induction Chemotherapy | Relapse-free Survival | 8 months |
| Consolidation Therapy | Relapse-free Survival | 7 months |