GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia

Sponsor
Yale University (Other)
Overall Status
Terminated
CT.gov ID
NCT04051996
Collaborator
Pfizer (Industry)
1
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multi-center, randomized phase 2 study is designed to evaluate the complete remission (including complete remission with incomplete count recovery) rates of glasdegib in combination with either decitabine on a 5-day or 10-day schedule in patients with newly-diagnosed poor-risk AML who either refuse or are ineligible for intensive therapy.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

The primary objective of this multi-center, randomized phase 2 study is to determine the response rates, complete remission (CR) and complete remission with incomplete count recovery (CRi), of glasdegib/DAC5 and glasdegib/DAC10 in patients with newly-diagnosed PrAML.

There are two secondary objectives for this study. The first secondary objective is to evaluate the toxicity and safety profiles of glasdegib/DAC5 and glasdegib/DAC10 in patients with newly-diagnosed PrAML. The other secondary objective is to determine the event-free survival (EFS), relapse-free survival (RFS), overall survival (OS), duration of response, bone marrow mutational clearance, and remission clonality of glasdegib/DAC5 and glasdegib/DAC10 in patients with newly-diagnosed PrAML.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Parallel-arm, Phase 2 Clinical Trial of the Combination of Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Who Are Unfit for or Refuse Intensive Chemotherapy (GLAD-AML)
Actual Study Start Date :
Dec 6, 2019
Actual Primary Completion Date :
Jun 9, 2020
Actual Study Completion Date :
Jun 9, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: DAC5

Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.

Drug: Glasdegib
Glasdegib will be administered at the starting dose of 100 mg orally once daily.

Drug: Decitabine
Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.

Experimental: DAC10

Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles.

Drug: Glasdegib
Glasdegib will be administered at the starting dose of 100 mg orally once daily.

Drug: Decitabine
Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.

Outcome Measures

Primary Outcome Measures

  1. CR/CRi [Up to 2 years]

    The complete remission (CR) and complete remission with incomplete count recovery (CRi) combined rate will be defined by the 2017 European LeukemiaNet (ELN) AML response criteria.

Secondary Outcome Measures

  1. OS [Up to 2 years]

    Overall survival (OS) is defined as the time from date of first study treatment to date of death due to any cause.

  2. EFS [Up to 2 years]

    Event-free survival (EFS) will be monitored up to 2 years.

  3. RFS [Up to 2 years]

    Relapse-free survival (RFS) will be monitored up to 2 years.

  4. Time to CR/CRi [Up to 2 years]

    The time to complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.

  5. Duration of CR/CRi [Up to 2 years]

    The duration of complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.

  6. Bone Marrow Mutational Clearance [Up to 2 years]

    Bone marrow mutational clearance of frequently-mutated genes in AML (e.g. NPM1, CEBPA, DNMT3A, RUNX1, TET2, IDH1/2) via next-generation DNA sequencing will be monitored up to 2 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients must have a morphologically-confirmed diagnosis of AML according to WHO 2016 classification with poor-risk disease as defined by the cytogenetic or molecular abnormalities (excluding FLT3-mutated AML).

  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.

  • Adequate Renal Function:

  1. Calculated creatinine clearance (determined by MDRD) ≥50mL/min/1.73m2, or serum creatinine <1.5x upper limit of normal (ULN);
  • Adequate Liver Function:
  1. Total serum bilirubin ≤ 2.0 x ULN (unless the bilirubin is principally unconjugated and there is strong suspicion of sub-clinical hemolysis or the patient has documented Gilbert's disease);

  2. Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3.0 x ULN;

  3. Alkaline phosphatase ≤ 3.0 x ULN.

  • Serum or urine pregnancy test (for female patients of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (HCG) negative at screening.

  • Males and female patients both of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for 180 days after the last dose of decitabine and the last dose of glasdegib, whichever occurs later.

  • Female patients who are not of childbearing potential (i.e. meet at least 1 of the following criteria):

  1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

  2. Have medically confirmed ovarian failure;

  3. Have achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.

Exclusion Criteria:
  • Patients who are candidates for and willing to receive intensive induction chemotherapy.

  • Prior use of a hypomethylating agent.

  • Prior use of cytotoxic chemotherapy for any myeloid malignancy (prior immunosuppressive therapy is permitted provided that treatment is stopped within 8 weeks from study entry; hydroxyurea is allowed through the end of cycle 1 on study).

  • Previous hematopoietic stem cell transplant.

  • Prior treatment with a licensed or experimental smoothened inhibitor (SMOi) and/or hypomethylating agent (HMA).

  • Participation in a clinical study involving an investigational drug(s) (Phases 1-4) within 4 weeks prior to study entry or within 5 half-lives of the investigational agent, whichever is greater.

  • Major surgery or radiation within 12 weeks prior to study entry.

  • Patients known to be refractory to platelet or packed red cell transfusions as per institutional guidelines, or who are known to refuse or who are likely to refuse blood product support.

  • Treatment with hematopoietic growth factors including: erythropoietin, granulocyte colony stimulating factor (G-CSF), and granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists within 3 weeks prior to study entry.

  • Any ongoing medical condition requiring chronic use of moderate to high dose steroids (defined as ≥10 mg/day of prednisone or equipotent dose of another corticosteroid).

  • Any anti-cancer treatment within 2 weeks prior to study entry (including hydroxyurea as above).

  • Current use or anticipated requirement for drugs that are known moderate to strong CYP3A4 inducers (Appendix 2).

  • Presence of concurrent active malignancy requiring active systemic therapy

  • Patients with known active, uncontrolled bacterial, fungal or viral infection, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.

  • Known uncontrolled central nervous system (CNS) involvement.

  • Poorly-controlled active medical conditions that as per investigator judgement would interfere with the conduct of the study.

  • Active cardiac dysrhythmias of NCI CTCAE Grade ≥2 (e.g. atrial fibrillation) or QTcF interval >470 msec.

  • Pregnant or breastfeeding female patients.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Yale Cancer Center/SmilowNew HavenConnecticutUnited States06511

Sponsors and Collaborators

  • Yale University
  • Pfizer

Investigators

  • Principal Investigator: Amer M Zeidan, MBBS, Yale University - MEDCCC Hematology-Section

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Amer Zeidan, Associate Professor of Internal Medicine (Hematology), Yale University
ClinicalTrials.gov Identifier:
NCT04051996
Other Study ID Numbers:
  • 2000024738
First Posted:
Aug 9, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Period Title: Overall Study
STARTED10
COMPLETED10
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleDAC5DAC10Total
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Total of all reporting groups
Overall Participants000
Age () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome
TitleCR/CRi
DescriptionThe complete remission (CR) and complete remission with incomplete count recovery (CRi) combined rate will be defined by the 2017 European LeukemiaNet (ELN) AML response criteria.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
2. Secondary Outcome
TitleOS
DescriptionOverall survival (OS) is defined as the time from date of first study treatment to date of death due to any cause.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
3. Secondary Outcome
TitleEFS
DescriptionEvent-free survival (EFS) will be monitored up to 2 years.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
4. Secondary Outcome
TitleRFS
DescriptionRelapse-free survival (RFS) will be monitored up to 2 years.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
5. Secondary Outcome
TitleTime to CR/CRi
DescriptionThe time to complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
6. Secondary Outcome
TitleDuration of CR/CRi
DescriptionThe duration of complete remission (CR) and complete remission with incomplete count recovery (CRi) will be collected as a secondary outcome.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00
7. Secondary Outcome
TitleBone Marrow Mutational Clearance
DescriptionBone marrow mutational clearance of frequently-mutated genes in AML (e.g. NPM1, CEBPA, DNMT3A, RUNX1, TET2, IDH1/2) via next-generation DNA sequencing will be monitored up to 2 years.
Time FrameUp to 2 years

Outcome Measure Data

Analysis Population Description
Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
Measure Participants00

Adverse Events

Time FrameUp to 2 years
Adverse Event Reporting Description There was only 1 patient enrolled in the study before termination and therefore there was only 1 treatment arm utilized.
Arm/Group TitleDAC5DAC10
Arm/Group DescriptionGlasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.Glasdegib will be administered at the starting dose of 100 mg orally once daily and continuously in combination with either DAC5 (decitabine 20 mg/m2 IV on a 5-day schedule) or DAC10 (decitabine 20 mg/m2 IV on a 10-day schedule) as per randomization. Treatment will be administered in 28-day cycles. Glasdegib: Glasdegib will be administered at the starting dose of 100 mg orally once daily. Decitabine: Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
All Cause Mortality
DAC5DAC10
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/1 (100%) 0/0 (NaN)
Serious Adverse Events
DAC5DAC10
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/1 (100%) 0/0 (NaN)
Injury, poisoning and procedural complications
Acute Kidney Injury1/1 (100%) 10/0 (NaN) 0
Respiratory, thoracic and mediastinal disorders
Dyspnea1/1 (100%) 10/0 (NaN) 0
Other (Not Including Serious) Adverse Events
DAC5DAC10
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/1 (0%) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Amer Zeidan
OrganizationYale University
Phone(203) 200-4363
Emailamer.zeidan@yale.edu
Responsible Party:
Amer Zeidan, Associate Professor of Internal Medicine (Hematology), Yale University
ClinicalTrials.gov Identifier:
NCT04051996
Other Study ID Numbers:
  • 2000024738
First Posted:
Aug 9, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021