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Anti-metabolites
Decitabine + Other Drugs for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Tapan M Kadia
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 of < or = 3
Patients aged >= 18 years AML who have achieved their FIRST complete response (CR) or complete response with incomplete bone marrow recovery (CRi) and are not immediately candidates for allogeneic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing decitabine given alone or with venetoclax, gilteritinib, enasidenib, or ivosidenib to find out if it can help control acute myeloid leukemia.
Who is the study for?
Adults aged 18+ with Acute Myeloid Leukemia in remission after intensive or lower intensity therapy, not immediately proceeding to stem cell transplant. Participants must have completed at least one consolidation cycle (intensive) or two cycles (lower intensity), be within certain health parameters, and agree to contraception.Check my eligibility
What is being tested?
This trial tests decitabine alone or combined with venetoclax, gilteritinib, enasidenib, or ivosidenib as maintenance therapy for AML in remission. It aims to see how these drugs affect cancer cell growth by killing them, stopping division/spread, and blocking proteins/enzymes needed for growth.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to the drugs, issues affecting blood cells leading to increased infection risk or bleeding problems, liver function changes indicated by bilirubin levels, kidney function impacts measured by creatinine levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am capable of limited self-care and spend less than half of my day in bed.
Select...
I am 18 or older with AML in my first complete response and not ready for a stem cell transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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
Secondary outcome measures
Duration of remission
Event-free survival (EFS)
Minimal residual disease
+2 moreOther outcome measures
RFS (Intensive induction cohort)
RFS (Lower intensity induction cohort)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Arm E (decitabine and cedazuridine, ivosidenib)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 and ivosidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm D (decitabine and cedazuridine, enasidenib)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 and enasidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm C (decitabine and cedazuridine, gilteritinib)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 and gilteritinib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: Arm B (decitabine and cedazuridine, venetoclax)Experimental Treatment2 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 and venetoclax PO QD on days 1-5. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group V: Arm A (decitabine and cedazuridine)Experimental Treatment1 Intervention
Patients receive decitabine and cedazuridine PO QD on days 1-3. Treatments repeat every 28 days for up to 4 weeks 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
Ivosidenib
2019
Completed Phase 1
~20
Gilteritinib
2014
Completed Phase 2
~560
Enasidenib
2020
Completed Phase 2
~560
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,192 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,557 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,048 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control or abstain from sex during and 30 days after treatment.I do not have a history of AML outside the bone marrow, except for controlled CNS involvement.I've had at least 2 rounds of mild treatment for my cancer and am now in remission.I have been diagnosed with a specific type of leukemia (APL or AML - M3).I can join the study at any time if my cancer is still detectable after initial treatment.I am willing to leave my current trial to join and receive treatment in a new trial.My leukemia is not the type that responds well to common treatments.I've had intensive therapy for my cancer and am not more than 2 months post my last treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have an active brain or spinal cord disease.I am a woman of childbearing age and meet the specific requirements.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am capable of limited self-care and spend less than half of my day in bed.You have a known allergy to any parts of the study treatment.I am 18 or older with AML in my first complete response and not ready for a stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (decitabine and cedazuridine, gilteritinib)
- Group 2: Arm D (decitabine and cedazuridine, enasidenib)
- Group 3: Arm E (decitabine and cedazuridine, ivosidenib)
- Group 4: Arm A (decitabine and cedazuridine)
- Group 5: Arm B (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable are Decitabine and Cedazuridine for long-term health benefits?
"From our assessment here at Power, the safety of Decitabine and Cedazuridine is given a score of 1 due to it being in Phase 1. Thus, there is only limited data that affirms its efficacy and security."
Answered by AI
Does this scientific experiment welcome new participants?
"The information published on clinicaltrials.gov indicates that this study, which was first made available on October 25th 2021, is currently looking for patients to participate. The details were most recently revised on August 10th 2022."
Answered by AI
What conditions respond most favorably to treatments with Decitabine and Cedazuridine?
"Decitabine and Cedazuridine are both viable treatments for those with intermediate-2 IPSS risk category, refractory anemias, or acute myelocytic leukemia."
Answered by AI
Has there been any previous research involving Decitabine and Cedazuridine?
"At present, 346 active trials are exploring Decitabine and Cedazuridine with 52 of those in the third stage. Most investigations into these drugs take place in Toronto, Ontario; however, there are 10772 sites conducting research on them worldwide."
Answered by AI
How many participants are accepted for enrollment in this research program?
"Affirmative. According to the details available on clinicaltrials.gov, this medical trial is accepting applicants and was first published in October 25th 2021 with an update made last August 10th 2022. 125 patients are needed from a single site for enrolment purposes."
Answered by AI
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