Trial Outcomes & Findings for Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia (NCT NCT03063203)
NCT ID: NCT03063203
Last Updated: 2022-06-02
Results Overview
* 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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
1 year
Results posted on
2022-06-02
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Chose alternative therapy
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease progression
|
4
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Decitabine
n=17 Participants
* 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
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Decitabine
n=17 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Overall Survival of Participants With TP53 Mutation
|
244 days
Interval 116.0 to 390.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Decitabine
n=17 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Percentage of Responding TP53 Mutated Patients (CR, CRi)
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Decitabine
n=7 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Time to Stem Cell Transplant Among Participants Who Are Suitable Candidates for Transplant and Have an Identified Donor
|
117 days
Interval 77.0 to 163.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Decitabine
n=4 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Median Time to Leukemia Relapse (TTLR) in Non-transplant Patients
|
308 days
Interval 64.0 to 374.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Decitabine
n=17 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Event-free Survival (EFS)
|
227 days
Interval 64.0 to 354.0
|
—
|
—
|
SECONDARY outcome
Timeframe: During cycles 1 and 2 (60 days)-Document number of hospital days that each participant stays and obtain average for all evaluable participants
Outcome measures
| Measure |
Decitabine
n=17 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Average Number of Hospital Days
|
10.3 days
Interval 2.0 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 12 weeksPopulation: 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.
* 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
Outcome measures
| Measure |
Decitabine
n=6 Participants
* 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
|
Molecularly Detected Disease
n=8 Participants
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
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
|
2 Participants
|
—
|
|
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
|
1 Participants
|
—
|
|
Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment
Stable Disease (SD)
|
2 Participants
|
4 Participants
|
—
|
|
Response Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment
Progressive disease (PD)
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Decitabine
n=8 Participants
* 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
|
Molecularly Detected Disease
n=9 Participants
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Survival Compared Between Patients With Morphologically Evident Disease Versus Patients With Molecularly Detected Disease at the Time of Enrollment
|
215 days
Interval 58.0 to 390.0
|
336 days
Interval 61.0 to 557.0
|
—
|
SECONDARY outcome
Timeframe: Through 12 weeksPopulation: 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.
-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations
Outcome measures
| Measure |
Decitabine
n=6 Participants
* 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
|
Molecularly Detected Disease
n=2 Participants
* 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
|
Patients With Treatment Related AML
n=6 Participants
* 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
|
|---|---|---|---|
|
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
|
0 Participants
|
2 Participants
|
|
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
|
0 Participants
|
1 Participants
|
|
Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML
Stable Disease (SD)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Response Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML
Progressive disease (PD)
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Decitabine
n=8 Participants
* 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
|
Molecularly Detected Disease
n=2 Participants
* 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
|
Patients With Treatment Related AML
n=7 Participants
* 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
|
|---|---|---|---|
|
Survival Compared Between Patients With de Novo AML Versus Patients With Secondary AML Versus Patients With Treatment-related AML
|
246 days
Interval 106.0 to 557.0
|
235 days
Interval 116.0 to 354.0
|
244 days
Interval 58.0 to 454.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Response was not evaluable for 3 patients with presence of cytogenetic abnormalities in addition to TP53 mutations as their response samples were hemodilute.
-Response will be assessed according to the 2017 European LeukemiaNet (ELN) Acute Myeloid Leukemia (AML) recommendations
Outcome measures
| Measure |
Decitabine
n=13 Participants
* 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
|
Molecularly Detected Disease
n=1 Participants
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
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
|
0 Participants
|
—
|
|
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
|
0 Participants
|
—
|
|
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
|
1 Participants
|
—
|
|
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
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Decitabine
n=16 Participants
* 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
|
Molecularly Detected Disease
n=1 Participants
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
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
Interval 116.0 to 390.0
|
NA days
The median survival with 95% confidence interval was not estimable due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: During cycles 1 and 2 (60 days)-Document number of hospital days that each participant stays and obtain median for all evaluable participants
Outcome measures
| Measure |
Decitabine
n=17 Participants
* 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
|
Molecularly Detected Disease
* 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
|
Patients With Treatment Related AML
* 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
|
|---|---|---|---|
|
Median Number of Hospital Stays
|
9 days
Interval 2.0 to 28.0
|
—
|
—
|
Adverse Events
Decitabine
Serious events: 4 serious events
Other events: 17 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Decitabine
n=17 participants at risk
* 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
|
|---|---|
|
Infections and infestations
Bacteremia streptococcus
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Facial cellulitis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Febrile neutropenia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
Other adverse events
| Measure |
Decitabine
n=17 participants at risk
* 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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Febrile neutropenia
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Cardiac disorders
Chest tightness
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Cardiac disorders
Heart failure
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Eye disorders
Diplopia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Eye disorders
Conjunctivitis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Heartburn
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Oral pain
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Stomach pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Knots
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Injection site reaction
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Localized edema - right breast
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Chills
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Edema limbs
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Fatigue
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Fever
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Infusion related reaction
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Cellulitis on shin
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Staphylococcus epidermis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Thrush
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Infections and infestations
Upper respiratory infection
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Alanine aminotransferase increased
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Alkaline phosphatase increased
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Aspartate aminotransferase increased
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Cardiac troponin I increased
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Creatinine increased
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Lymphocyte count decreased
|
52.9%
9/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Neutrophil count decreased
|
35.3%
6/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Platelet count decreased
|
29.4%
5/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
Weight loss
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Investigations
White blood cell decreased
|
41.2%
7/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Acidosis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.4%
5/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Nervous system disorders
Dizziness
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Psychiatric disorders
Hallucinations
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Renal and urinary disorders
Acute kidney injury
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.5%
4/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Skin and subcutaneous tissue disorders
Oily skin
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Skin and subcutaneous tissue disorders
Traumatic fat necrosis
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
17.6%
3/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Adverse events were collected from time of consent until 30 days after last dose of therapy (may continue until time of transplantation or disease progression - estimated time of 3-6 months). All-cause mortality was collected from time of consent through completion of follow-up (for 2 years after last dose of decitabine or until the patient is lost to follow-up or dies).
|
Additional Information
John Welch, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-362-2626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place