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Anti-metabolites

Decitabine/Cedazuridine + Venetoclax + Ivosidenib/Enasidenib for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Courtney DiNardo
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
Adequate renal function including creatinine < 2 unless related to the disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing the side effects of a new drug combo and how well it works on patients with a certain type of leukemia.

Who is the study for?
This trial is for adults over 18 with relapsed or refractory acute myeloid leukemia, including those not eligible for intensive chemotherapy due to age (>60). Participants must have an IDH1 or IDH2 gene mutation, be able to perform daily activities (ECOG <=2), and have adequate kidney and liver function. Men must use contraception.Check my eligibility
What is being tested?
The trial tests a combination of decitabine/cedazuridine (ASTX727) and venetoclax with either ivosidenib or enasidenib. It aims to see how well these drugs work together in treating AML that's resistant or has returned after treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system, digestive issues, abnormal blood counts leading to increased infection risk, liver problems, fatigue, and potential complications from organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal, with creatinine levels below 2.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My cancer has an IDH1 or IDH2 gene mutation.
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I have been diagnosed with a type of leukemia that has returned or is not responding to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Dose limiting toxicity (Phase Ib)
Incidence of adverse events (Phase II)
Overall response rate (ORR) (Phase II)
Secondary outcome measures
Duration of response
Event-free survival (EFS)
Minimal residual disease negative status
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (decitabine/cedazuridine, venetoclax, enasidenib)Experimental Treatment3 Interventions
Patients receive decitabine/cedazuridine PO daily on days 1-5, venetoclax PO daily on days 1-14, and enasidenib PO daily on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (decitabine/cedazuridine, venetoclax, ivosidenib)Experimental Treatment3 Interventions
Patients receive decitabine/cedazuridine PO daily on days 1-5, venetoclax PO daily on days 1-14, and ivosidenib PO daily on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enasidenib
2020
Completed Phase 2
~560
Ivosidenib
2019
Completed Phase 1
~20
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,262 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
625 Total Patients Enrolled
Courtney DiNardo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
10 Previous Clinical Trials
510 Total Patients Enrolled

Media Library

Acute Myelogenous Leukemia Research Study Groups: Arm A (decitabine/cedazuridine, venetoclax, ivosidenib), Arm B (decitabine/cedazuridine, venetoclax, enasidenib)

Frequently Asked Questions

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

Are there any similar ongoing or past research projects involving Decitabine and Cedazuridine?

"As of now, there are 345 ongoing trials for Decitabine and Cedazuridine with 47 trials in Phase 3. While several of the trials for Decitabine and Cedazuridine are located in Edmonton, Alberta, there are 9849 locations running clinical trials for Decitabine and Cedazuridine."

Answered by AI

How many individuals are participating in this clinical research?

"That is correct. The clinicaltrials.gov website shows that this study posted on May 24th, 2021 and was edited on October 12th, 2020 is still recruiting patients. They are looking to enroll 84 participants from 1 site."

Answered by AI

Are there any patients that you are still looking for to enroll in your research?

"According to the most updated information on clinicaltrials.gov, this trial is actively looking for participants. The original posting was on May 24th, 2021 and the listing was edited October 12th, 2022."

Answered by AI

Decitabine and Cedazuridine are most often given to patients for what reason?

"The most common course of treatment for refractory anemias is Decitabine and Cedazuridine. This medication is also effective against leukemia, myelocytic, acute, muscular dystrophy, and susceptible idh1 mutation."

Answered by AI

What is the main goal of this clinical trial?

"The purpose of this trial, which will be conducted over the course of 4 months, is to observe and document adverse events (Phase II). Additionally, researchers will also track patients' Event-free survival (EFS), Duration of response, and Minimal residual disease negative status. All outcomes will have data collected via the Kaplan-Meier method with subsequent log-rank tests to compare among patient subgroups. There is also an objective to understand the relationship between molecular and cellular markers and overall response or resistance through logistic regression analyses. To do so, changes over time will be observed using a paired t-test or Wilcoxon signed"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
2021. "Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774393.
~14 spots leftby Nov 2024
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