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Cytidine Deaminase Inhibitor
Decitabine + Cedazuridine + Venetoclax for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Sanjay Mohan, MD
Research Sponsored by Sanjay Mohan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment.
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat a type of leukemia that has come back after a stem cell transplant. The drugs work by helping make normal blood cells and killing abnormal cells.
Who is the study for?
This trial is for adults over 18 with relapsed Acute Myeloid Leukemia (AML) after a donor stem cell transplant. Participants must have adequate organ function, not be pregnant or breastfeeding, and cannot have active graft versus host disease or other uncontrolled conditions. They should not have received certain treatments recently and must be able to take oral medication.Check my eligibility
What is being tested?
The trial tests a combination of decitabine and cedazuridine (DEC-C) with venetoclax in patients whose AML has returned post-transplant. DEC-C may help the bone marrow produce healthy cells and kill cancer cells, while venetoclax targets proteins essential for cancer cell survival.See study design
What are the potential side effects?
Potential side effects include digestive issues, fatigue, liver problems reflected by altered blood tests, potential kidney dysfunction as measured by creatinine clearance levels, risk of infection due to weakened immune system response from the treatment regimen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months post-treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite complete response (CR) rate (CR/complete response with partial recovery of peripheral blood counts [CRh]/complete remission with incomplete hematological recovery [CRi])
Secondary outcome measures
Incidence of adverse events
Rate of measurable residual disease negativity in patients achieving a CR
Rate of morphologic leukemia free state (MLFS) following treatment with DEC-C/venetoclax
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Venetoclax, DEC-C)Experimental Treatment5 Interventions
Patients receive venetoclax PO daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Biospecimen Collection
2004
Completed Phase 2
~1700
Decitabine
2004
Completed Phase 3
~1680
Cedazuridine
2021
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,533 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,584 Total Patients Enrolled
Sanjay MohanLead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection that isn't under control.I cannot take pills or have severe stomach/intestine problems.I am experiencing active symptoms from a graft versus host disease.I have recovered from previous cancer treatment side effects.I have leukemia that has spread to my brain.My AML has returned after a stem cell transplant.I haven't had cancer treatment in the last 2 weeks or within 5 half-lives of the drug.I am not currently being treated for another cancer, nor expected to be in the next 6 months.I have had a stem cell transplant or similar therapy in the last 3 months.I am not taking any medications that are not allowed in this trial.I have had a bone marrow biopsy to collect tissue for this trial.I am 18 or older and agree to participate in the study.My condition worsened while on venetoclax or another BCL-2 inhibitor.I have had a serious heart condition in the last 6 months.I can take care of myself and am up and about more than 50% of my waking hours.My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).I have not had radiation or major surgery in the last 3 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Venetoclax, DEC-C)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have the FDA sanctioned Venetoclax and DEC-C as viable treatments?
"The safety of this treatment, which combines Venetoclax and DEC-C, was given a score of 2 since it is only in its second phase. This means there are some data to support the drug's protection but no studies demonstrating efficacy yet."
Answered by AI
Is this research recruiting new participants?
"Per the clinicaltrials.gov records, this research endeavour is not currently open for recruitment. It was initially posted on May 1st 2023 and its last update happened on March 22nd of the same year. Despite that, there are many other trials actively looking to enrol participants at present – 1486 in total."
Answered by AI
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