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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
Must not have
Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment
Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French-American-British (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a history of AML outside the bone marrow, except for controlled CNS involvement.
Select...
I have been diagnosed with a specific type of leukemia (APL or AML - M3).
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have an active brain or spinal cord disease.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Duration of remission
Event-free survival (EFS)
Minimal residual disease
+2 moreOther study objectives
RFS (Intensive induction cohort)
RFS (Lower intensity induction cohort)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Ivosidenib
2019
Completed Phase 1
~20
Venetoclax
2019
Completed Phase 3
~2240
Gilteritinib
2014
Completed Phase 2
~660
Enasidenib
2020
Completed Phase 2
~610
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,484 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,935 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,145 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.
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