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Venetoclax + Decitabine/Cedazuridine for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Marina Konopleva
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a possible treatment for acute myeloid leukemia.
Who is the study for?
Adults (18+) with relapsed or refractory Acute Myeloid Leukemia, including biphenotypic leukemia with a myeloid component. Participants must have adequate organ function and performance status, agree to use effective contraception, and be able to consent. Excluded are those with severe conditions affecting drug absorption, uncontrolled illnesses, active hepatitis B/C or HIV, high white cell count without hydroxyurea treatment, pregnant or nursing women not using contraception, certain genetic abnormalities in their leukemia cells (t(15;17)), symptomatic CNS leukemia or active graft-versus-host disease.Check my eligibility
What is being tested?
The trial is testing the combination of venetoclax with decitabine and cedazuridine for patients whose AML has returned after treatment or hasn't responded to other treatments. Venetoclax targets cancer cells' survival mechanisms while decitabine interferes with their DNA replication. Cedazuridine inhibits enzymes that could break down these drugs before they work.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea due to chemotherapy's effect on the digestive system; low blood counts leading to increased infection risk; liver enzyme changes indicating potential liver impact; fatigue from overall body stress caused by treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My leukemia has returned or didn't respond to treatment, including if it's only outside the bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall response rate (ORR)
Secondary outcome measures
Duration of response
Event-free survival (EFS)
Gene expression profiles
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine and cedazuridine, venetoclax)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-10. Patients who achieve CR/CRi during consolidation/maintenance may receive decitabine and cedazuridine PO QD on days 1-5. Patients also receive venetoclax PO QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1950
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,215 Total Patients Enrolled
Marina KonoplevaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
252 Total Patients Enrolled
Abhishek MaitiPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 7 days, except for specific cases approved by my doctor.I don't have severe stomach or metabolic issues affecting medication absorption.My leukemia is of a specific type known as acute promyelocytic (M3-AML).I can take care of myself and perform daily activities.I am 18 years old or older.I agree to avoid unprotected sex and not donate sperm for 90 days after my last dose.My white blood cell count is above the required level.I don't have active graft-versus-host disease after a stem cell transplant.I am not pregnant, nursing, or if capable of becoming pregnant, I agree to use contraception.My leukemia has returned or didn't respond to treatment, including if it's only outside the bone marrow.My leukemia is affecting my brain and is not well-controlled.I do not have any severe ongoing health issues like uncontrolled infections, high blood pressure, heart failure, or irregular heartbeats.I have an active hepatitis B, hepatitis C, or HIV infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (decitabine and cedazuridine, venetoclax)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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