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Venetoclax + Decitabine/Cedazuridine for Acute Myeloid Leukemia

Phase 2
Recruiting
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

Trial 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
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,961 Previous Clinical Trials
1,803,264 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

Cedazuridine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04975919 — Phase 2
Acute Myelogenous Leukemia Research Study Groups: Treatment (decitabine and cedazuridine, venetoclax)
Acute Myelogenous Leukemia Clinical Trial 2023: Cedazuridine Highlights & Side Effects. Trial Name: NCT04975919 — Phase 2
Cedazuridine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975919 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment have any vacancies for participants?

"Confirmed. Clinicaltrials.gov reveals that enrollment for this research project is currently underway, having been first announced on September 29th 2021 and most recently updated on July 17th 2022. 20 individuals need to be recruited from a single medical facility."

Answered by AI

What maladies have Decitabine and Cedazuridine been proven to address?

"Refractory anemia is typically managed with Decitabine and Cedazuridine, though they may also be beneficial in treating conditions like chronic lymphocytic leukemia (CLL), intermediate-1 International Prognostic Scoring System risk category, and intermediate-2 IPSS risk category."

Answered by AI

Has the FDA sanctioned Decitabine and Cedazuridine for therapeutic use?

"Our in-house experts have graded the safety of Decitabine and Cedazuridine to be a 2, as Phase 2 trials are yet to provide evidence of efficacy but there is some data that supports their safety."

Answered by AI

What is the aggregate number of participants involved in this trial?

"Affirmative. Clinicaltrials.gov attests that this clinical trial is currently recruiting participants, having been originally posted on September 29th 2021 and last revised on July 17th 2022. 20 test subjects are required from a single medical site."

Answered by AI

Have researchers previously conducted any experiments that incorporate Decitabine and Cedazuridine?

"At the present time, there are 304 clinical trials underway to evaluate Decitabine and Cedazuridine. 43 of these investigations fall within Phase 3 studies while 8584 medical sites across North America are running related experiments. Toronto is notably hosting many of these ongoing assessments."

Answered by AI
~6 spots leftby May 2025