Acute Myeloid Leukemia, Acute Myeloid Leukemia, Relapsed, Adult
Conditions
Brief summary
In this study, the investigators seek to determine whether decitabine therapy can improve outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML) patients with the poorest prognosis based on refractoriness to induction treatment and high risk genetic mutations.
Interventions
DRUGDecitabine
* After 2 cycles, patients with progressive disease or relapse (a clear progression with at least \>20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference * Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant * Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference * Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles * Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses * Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference.
PROCEDUREBone marrow biopsy/aspirate
* Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse * Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only * Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician
PROCEDUREPeripheral blood draw
-Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse
PROCEDURESkin biopsy
* Optional but if refuse skin biopsy then participant can provided buccal swab * There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine * If WBC at time of enrollment is \>30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter
PROCEDUREBuccal swab
-Baseline (if skin biopsy declined) and Cycle 2 Day 28
Sponsors
Janssen Pharmaceuticals
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* TP53 mutant AML. The presence of a TP53 mutation should be determined by Genoptix (or institutional preferred equivalent assay). Detection of a TP53 mutation at the time of initial diagnosis is sufficient for enrollment at the time of relapsed/refractory disease. Detection of a TP53 mutation in either the peripheral blood or bone marrow is adequate for enrollment. Alternatively, patients who have not had TP53 mutation analysis performed, but who have \> 20% TP53 positive cells by immunohistochemistry detected on a bone marrow aspirate may also be enrolled,29 provided that mutation analysis is requested at the time of enrollment. * Relapsed/refractory AML following 7+3 (or similar cytarabine containing induction chemotherapy for AML) disease detected by one of the following methods: * bone marrow blasts \> 5%, or * Hematologics flow cytometry assay (threshold \> 0.5%) (alternative equivalent assay may be substituted), or * Persistent cytogenetic abnormality (e.g. del5, del17p, etc), by FISH or conventional karotyping, or * Persistent TP53 mutation (at least 5 variant reads with at least 50x coverage) determined by Genoptix (or institutional preferred equivalent assay). * Patients with \> 10% blasts on a day +14 bone marrow biopsy following 7+3 may either be enrolled or may be treated with a course of standard re-induction (e.g. 5+2 or similar) and then re-evaluated for response. Eligible patients will meet any of the above criteria on a subsequent biopsy. * Bone marrow and organ function as defined below: * Peripheral white blood cell count \< 50,000/mcl (patients may receive hydroxyurea as necessary for cytoreduction), * Total bilirubin \< 1.5 x upper limit of normal, * AST and ALT \< 2.5 x upper limit of normal, * Serum creatinine \< 2.0 x upper limit of normal, and, * At least 18 years of age. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable * Performance status ≤ 3
Exclusion criteria
* Prior treatment with either decitabine or azacitidine or an investigational agent * Acute promyelocytic leukemia with PML-RARA or t(15;17). * History of HIV, Hepatitis B, or Hepatitis C infection. * Concurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic NYHA class 3 or 4 congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Radiation therapy within 14 days of enrollment. * Chemotherapy administration in the 7 days preceding enrollment with the exception of hydroxyurea, which can be continued until Cycle 2. A washout period for oral tyrosine kinase inhibitors (e.g. Jakafi, etc) is not required, although tyrosine kinase inhibitors therapy must be discontinued prior to enrollment. * Malignancies (other than AML) requiring active therapy or diagnosed within the last year, with the exception of non-melanoma skin cancer which can be treated or in situ malignancies (such as cervical, breast, prostate, etc.) * Currently receiving any other investigational agents. * Known central nervous system (CNS) leukemia or testicular involvement of leukemia * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 7 days of study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival of Participants With TP53 Mutation | 1 year | * Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive * To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor | 12 weeks | * Document the number of days that it takes each participant to reach transplant * Transplant eligible participants are those who achieve complete remission (CR), cytogenetic complete remission (CRc), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia free state (mLFS) per 2017 ELN AML Recommendations. |
| Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients | 2 years | -Recurrence/morphologic relapse - Defined as relapse following complete remission is defined as reappearance of blasts in the blood or the finding of ≥ 5% blasts in the bone marrow, not attributable to any other cause. New dysplastic changes is considered relapse. If there are no blasts in the peripheral blood and 5-20% blasts in the bone marrow, bone marrow biopsy should be repeated in \> 1 week to confirm relapse. |
| Event-free Survival (EFS) | 2 year | -Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, death due to any cause, or loss to follow up. |
| Average Number of Hospital Days | During cycles 1 and 2 (60 days) | -Document number of hospital days that each participant stays and obtain average for all evaluable participants |
| Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Through 12 weeks | * Morphologically evident disease (\>5% blasts by cytomorphology) * Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis if ≤ 5% blasts by cytomorphology) * Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations |
| Percentage of Responding TP53 Mutated Patients (CR, CRi) | 12 weeks | * Complete remission (CR) - Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1,000/μL); platelet count \>100 x 109/L (100,000/μL). * Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - \<1.0 x 109/L (1,000/μL) or thrombocytopenia -\<100 x 109/L (100,000/μL) |
| Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Through 12 weeks | -Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations |
| Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | 2 years | — |
| Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | 12 weeks | -Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations |
| Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | 2 years | — |
| Median Number of Hospital Stays | During cycles 1 and 2 (60 days) | -Document number of hospital days that each participant stays and obtain median for all evaluable participants |
| Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | 2 years | * Morphologically evident disease (\>5% blasts by cytomorphology) * Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis with ≤ 5% blasts by cytomorphology) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decitabine * Cycle 1: All patients will receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle
* Cycle 2: Patients with bone marrow blast counts \< 5% may receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m\^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.
* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m\^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Chose alternative therapy | 3 |
| Overall Study | Death | 2 |
| Overall Study | Disease progression | 4 |
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | Decitabine |
|---|---|
| Age, Continuous | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 17 |
| other Total, other adverse events | 17 / 17 |
| serious Total, serious adverse events | 4 / 17 |
Outcome results
Primary
Overall Survival of Participants With TP53 Mutation
* Overall survival (OS) is defined as the time from enrollment to death due to any cause. For a patient who is not known to be alive at the end of study follow up, observation of OS is censored on the date the patient was last known to be alive * To be evaluable for this outcome measure the participant would have to have received at least one dose of decitabine
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Overall Survival of Participants With TP53 Mutation | 244 days |
Secondary
Average Number of Hospital Days
-Document number of hospital days that each participant stays and obtain average for all evaluable participants
Time frame: During cycles 1 and 2 (60 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Decitabine | Average Number of Hospital Days | 10.3 days |
Secondary
Event-free Survival (EFS)
-Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, death due to any cause, or loss to follow up.
Time frame: 2 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Event-free Survival (EFS) | 227 days |
Secondary
Median Number of Hospital Stays
-Document number of hospital days that each participant stays and obtain median for all evaluable participants
Time frame: During cycles 1 and 2 (60 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Median Number of Hospital Stays | 9 days |
Secondary
Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients
-Recurrence/morphologic relapse - Defined as relapse following complete remission is defined as reappearance of blasts in the blood or the finding of ≥ 5% blasts in the bone marrow, not attributable to any other cause. New dysplastic changes is considered relapse. If there are no blasts in the peripheral blood and 5-20% blasts in the bone marrow, bone marrow biopsy should be repeated in \> 1 week to confirm relapse.
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients | 308 days |
Secondary
Percentage of Responding TP53 Mutated Patients (CR, CRi)
* Complete remission (CR) - Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1,000/μL); platelet count \>100 x 109/L (100,000/μL). * Complete remission with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia - \<1.0 x 109/L (1,000/μL) or thrombocytopenia -\<100 x 109/L (100,000/μL)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decitabine | Percentage of Responding TP53 Mutated Patients (CR, CRi) | 5 Participants |
Secondary
Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML
-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations
Time frame: Through 12 weeks
Population: 2 patients with de novo AML were not evaluable for this outcome measure because the samples were hemodilute. 1 patient with treatment related AML was not evaluable for this outcome measure because the samples were hemodilute.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decitabine | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Complete remission with incomplete hematologic recovery (CRi) | 3 Participants |
| Decitabine | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Morphologic leukemia free state (mLFS) | 0 Participants |
| Decitabine | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Stable Disease (SD) | 3 Participants |
| Decitabine | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Progressive disease (PD) | 0 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Progressive disease (PD) | 1 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Complete remission with incomplete hematologic recovery (CRi) | 0 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Stable Disease (SD) | 1 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Morphologic leukemia free state (mLFS) | 0 Participants |
| Patients With Treatment Related AML | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Progressive disease (PD) | 1 Participants |
| Patients With Treatment Related AML | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Morphologic leukemia free state (mLFS) | 1 Participants |
| Patients With Treatment Related AML | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Stable Disease (SD) | 2 Participants |
| Patients With Treatment Related AML | Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | Complete remission with incomplete hematologic recovery (CRi) | 2 Participants |
Secondary
Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment
* Morphologically evident disease (\>5% blasts by cytomorphology) * Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis if ≤ 5% blasts by cytomorphology) * Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations
Time frame: Through 12 weeks
Population: Response was not evaluable for 2 patients with molecularly evident disease as their samples were hemodilute. Response was not evaluable for 1 patient with molecularly detected disease as their sample was hemodilute.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decitabine | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Complete remission with incomplete hematologic recovery (CRi) | 3 Participants |
| Decitabine | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Morphologic leukemia free state (mLFS) | 0 Participants |
| Decitabine | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Stable Disease (SD) | 2 Participants |
| Decitabine | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Progressive disease (PD) | 1 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Progressive disease (PD) | 1 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Complete remission with incomplete hematologic recovery (CRi) | 2 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Stable Disease (SD) | 4 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | Morphologic leukemia free state (mLFS) | 1 Participants |
Secondary
Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations
-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations
Time frame: 12 weeks
Population: Response was not evaluable for 3 patients with presence of cytogenetic abnormalities in addition to TP53 mutations as their response samples were hemodilute.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decitabine | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Complete remission with incomplete hematologic recovery (CRi) | 5 Participants |
| Decitabine | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Morphologic leukemia free state (mLFS) | 1 Participants |
| Decitabine | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Stable Disease (SD) | 5 Participants |
| Decitabine | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Progressive disease (PD) | 2 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Progressive disease (PD) | 0 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Complete remission with incomplete hematologic recovery (CRi) | 0 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Stable Disease (SD) | 1 Participants |
| Molecularly Detected Disease | Response Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | Morphologic leukemia free state (mLFS) | 0 Participants |
Secondary
Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | 246 days |
| Molecularly Detected Disease | Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | 235 days |
| Patients With Treatment Related AML | Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML | 244 days |
Secondary
Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment
* Morphologically evident disease (\>5% blasts by cytomorphology) * Molecularly detected disease (disease detected with flow cytometry, cytogenetic, or mutational analysis with ≤ 5% blasts by cytomorphology)
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | 215 days |
| Molecularly Detected Disease | Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment | 336 days |
Secondary
Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | 254 days |
| Molecularly Detected Disease | Survival Compared Between Patients With Presence of Cytogenetic Abnormalities in Addition to TP53 Mutations Versus Patients With Absence of Cytogenetic Abnormalities in Addition to TP53 Mutations | NA days |
Secondary
Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor
* Document the number of days that it takes each participant to reach transplant * Transplant eligible participants are those who achieve complete remission (CR), cytogenetic complete remission (CRc), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia free state (mLFS) per 2017 ELN AML Recommendations.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Decitabine | Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor | 117 days |