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Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00658814
Enrollment
133
Registered
2008-04-15
Start date
2008-12-01
Completion date
2027-03-31
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

DRUGAzacitidine

Given IV or SC during induction; given SC during consolidation and maintenance

DRUGGemtuzumab Ozogamicin

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Complete ResponseUp to 60 daysMorphologic 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 Survival30 daysPatients surviving more than 30 days after study registration

Secondary

MeasureTime frameDescription
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugUp to 5 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.
Relapse-free SurvivalUp to 5 yearsRelapse-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

PRINCIPAL_INVESTIGATORSucha Nand

SWOG Cancer Research Network

Participant flow

Participants by arm

ArmCount
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
Total133

Baseline characteristics

CharacteristicPoor Risk Patients: Azacitidine Plus Gemtuzumab OzogamicinTotalGood Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Age, Continuous76 years73.4 years71.2 years
Hispanic
No
50 participants114 participants64 participants
Hispanic
Unknown
3 participants15 participants12 participants
Hispanic
Yes
1 participants4 participants3 participants
Race/Ethnicity, Customized
Asian
0 participants1 participants1 participants
Race/Ethnicity, Customized
Black or African American
4 participants5 participants1 participants
Race/Ethnicity, Customized
White
50 participants127 participants77 participants
Sex: Female, Male
Female
21 Participants51 Participants30 Participants
Sex: Female, Male
Male
33 Participants82 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
other
Total, other adverse events
130 / 13332 / 3226 / 27
serious
Total, serious adverse events
55 / 1331 / 323 / 27

Outcome results

Primary

30-Day Survival

Patients surviving more than 30 days after study registration

Time frame: 30 days

ArmMeasureValue (NUMBER)
Remission Induction Chemotherapy30-Day Survival92 percentage of participants
Consolidation Therapy30-Day Survival87 percentage of participants
Primary

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

ArmMeasureValue (NUMBER)
Remission Induction ChemotherapyComplete Response44 percentage of participants
Consolidation TherapyComplete Response35 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Skin (cellulitis)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugGlucose, serum-high (hyperglycemia)10 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-cardiopulmonary disease1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Lung (pneumonia)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin73 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT4 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Blood1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, CNS1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Stomach1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-Chest Pain1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Lung0 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Upper GI NOS1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - SVT tachycardia1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Blood2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage/Bleeding-platelets and red blood cells1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - UTI3 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHepatobiliary/Pancreas-venoocclusive disease1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac troponin I (cTnI)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Skin6 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypertension1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Sinus2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypotension2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPlatelets85 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypoxia4 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac-ischemia/infarction1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Lung8 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Blood16 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Kidney1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)4 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth3 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Colon1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConduction abnormality NOS1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - Atrial fibrillation2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPetechiae/purpura (hemorrhage into skin or mucosa)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConfusion1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)3 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Cardiac/heart2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConstipation2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSudden death1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)85 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCytokine release syndrome/acute infusion reaction1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general4 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Disease progression NOS1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCalcium, serum-low (hypocalcemia)6 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (functional/symp) - Oral cav1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Multi-organ failure2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAdult respiratory distress syndrome (ARDS)1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMood alteration - depression2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath not associated with CTCAE term - Death NOS1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary/Upper Respiratory-pulmonary edema2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLymphopenia23 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCarbon monoxide diffusion capacity (DL(co))1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLiver dysfunction/failure (clinical)0 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugThrombosis/thrombus/embolism2 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeukocytes (total WBC)80 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugEdema: limb1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac Arrhythmia-Atrial fibrilation1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-bacteremia1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)18 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)5 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-Aspirgillosis1 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFebrile neutropenia50 Participants
Remission Induction ChemotherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAdult respiratory distress syndrome (ARDS)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCalcium, serum-low (hypocalcemia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCarbon monoxide diffusion capacity (DL(co))0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac Arrhythmia-Atrial fibrilation0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-cardiopulmonary disease0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-Chest Pain0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac troponin I (cTnI)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac-ischemia/infarction0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConduction abnormality NOS0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConfusion0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConstipation0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCytokine release syndrome/acute infusion reaction0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Disease progression NOS0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Multi-organ failure0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath not associated with CTCAE term - Death NOS0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugEdema: limb0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFebrile neutropenia0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugGlucose, serum-high (hyperglycemia)3 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, CNS0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Stomach0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Upper GI NOS0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage/Bleeding-platelets and red blood cells0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHepatobiliary/Pancreas-venoocclusive disease0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypertension0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypotension0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypoxia0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Blood0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Colon0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Kidney0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Lung0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Sinus0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Skin0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - UTI0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Blood1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Lung0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Blood0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Lung (pneumonia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Skin (cellulitis)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-Aspirgillosis0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-bacteremia0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeukocytes (total WBC)18 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLiver dysfunction/failure (clinical)1 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLymphopenia0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMood alteration - depression0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (functional/symp) - Oral cav0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)21 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Cardiac/heart0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPetechiae/purpura (hemorrhage into skin or mucosa)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPlatelets12 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary/Upper Respiratory-pulmonary edema0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - Atrial fibrillation0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - SVT tachycardia0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSudden death0 Participants
Consolidation TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugThrombosis/thrombus/embolism0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Lung (pneumonia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFebrile neutropenia0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCarbon monoxide diffusion capacity (DL(co))0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Skin (cellulitis)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)1 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-Aspirgillosis0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugEdema: limb0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection-bacteremia0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)2 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCalcium, serum-low (hypocalcemia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeukocytes (total WBC)6 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary/Upper Respiratory-pulmonary edema0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLiver dysfunction/failure (clinical)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath not associated with CTCAE term - Death NOS0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLymphopenia1 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Multi-organ failure0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMood alteration - depression0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDeath - Disease progression NOS0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (functional/symp) - Oral cav0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCytokine release syndrome/acute infusion reaction0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConstipation0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugThrombosis/thrombus/embolism0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)10 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConfusion0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - Atrial fibrillation0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Cardiac/heart0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugConduction abnormality NOS0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Colon0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPetechiae/purpura (hemorrhage into skin or mucosa)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac-ischemia/infarction0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Blood1 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSudden death0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Kidney0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypoxia0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Lung0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypotension0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac troponin I (cTnI)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHypertension0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSVT and nodal arrhythmia - SVT tachycardia0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Sinus0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHepatobiliary/Pancreas-venoocclusive disease0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPlatelets3 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Skin0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage/Bleeding-platelets and red blood cells0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-Chest Pain0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - UTI0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Upper GI NOS0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac General-cardiopulmonary disease0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Blood0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Stomach0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Lung1 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemorrhage, CNS0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugCardiac Arrhythmia-Atrial fibrilation0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin1 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAdult respiratory distress syndrome (ARDS)0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Blood0 Participants
Maintenance TherapyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugGlucose, serum-high (hyperglycemia)2 Participants
Secondary

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

ArmMeasureValue (MEDIAN)
Remission Induction ChemotherapyRelapse-free Survival8 months
Consolidation TherapyRelapse-free Survival7 months

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026