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Enasidenib for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Amandeep Salhotra

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x ULN, patients with abnormal liver function tests (LFTs) in the context of active GVHD will not be included (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)

Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky performance status (KPS) >= 70

Must not have

Females only: Pregnant or breastfeeding

Active infection requiring antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from starting enasidenib to date of death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if enasidenib is a safe and effective maintenance therapy for patients with acute myeloid leukemia who have had a donor stem cell transplant.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) and an IDH2 mutation who've had a donor stem cell transplant. They must not be pregnant, have good organ function, no severe active infections or other cancers, and agree to birth control. People with Gilbert's disease or uncontrolled illnesses can't join.

What is being tested?

Enasidenib Mesylate is being tested as a maintenance therapy for AML patients post-stem cell transplant. The study aims to see if this drug can prevent cancer growth by inhibiting certain enzymes needed by cancer cells.

What are the potential side effects?

Possible side effects of Enasidenib include liver problems, blood disorders, fatigue, nausea, diarrhea, joint pain and may affect heart rhythm which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are normal or near normal.

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I am mostly self-sufficient and can carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am currently taking antibiotics for an infection.

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I am currently being treated with steroids for acute GVHD.

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I have severe diarrhea that could affect taking medication by mouth.

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I have a serious health condition that is not under control.

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I have been diagnosed with Gilbert's disease.

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I have a history of HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from starting enasidenib to date of death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from starting enasidenib to date of death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from starting enasidenib to date of death, assessed up to 2 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 (AEs)

Secondary study objectives

Graft versus host disease (GvHD)-free relapse free survival (GRFS)

Leukemia free survival (LFS)

Non-relapse mortality (NRM)

+2 more

Other study objectives

IDH2 mutation clearance (BM and peripheral blood)

Minimal residual disease (MRD) disappearance (bone marrow [BM])

mIDH2 variant allele fraction (BM)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (enasidenib mesylate)Experimental Treatment1 Intervention

Patients receive enasidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

0 / 9Eligibility criteria met