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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 below

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I am capable of limited self-care and spend less than half of my day in bed.

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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:

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I do not have a history of AML outside the bone marrow, except for controlled CNS involvement.

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I have been diagnosed with a specific type of leukemia (APL or AML - M3).

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have an active brain or spinal cord disease.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Other 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

~2200