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Enasidenib for Acute Myeloid Leukemia

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Secondary outcome measures

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

Leukemia free survival (LFS)

Non-relapse mortality (NRM)

+2 more

Other outcome measures

IDH2 mutation clearance (BM and peripheral blood)

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

mIDH2 variant allele fraction (BM)

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,652 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,445 Total Patients Enrolled

Amandeep SalhotraPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

78 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies in this trial for participants?

"This trial is no longer open to participants, with its last update occuring on June 7th 2022. However, if you are still eager to join a clinical study there are currently 1535 trials actively recruiting patients with leukemia and 53 studies specifically for Enasidenib Mesylate."

Answered by AI

How many individuals are participating in this clinical investigation?

"As of this time, the trial is not actively recruiting participants. Originally posted on July 11th 2019 and last updated on June 7th 2022, individuals seeking to participate in a clinical study should look elsewhere; there are presently 1535 trials for leukemia, myelocytic acute patients and 53 trials involving enasidenib mesylate that are currently looking for volunteers."

Answered by AI

Has Enasidenib Mesylate received governmental authorization for public use?

"The safety of Enasidenib Mesylate is tentatively assessed at a score 1, given that this medication has only been tested in Phase 1 trials with limited evidence of efficacy and safety."

Answered by AI

What other experiments have been conducted to assess the efficacy of Enasidenib Mesylate?

"Initially tested in 2011 at the Memorial Sloan Kettering Cancer Centre, enasidenib mesylate has since been the subject of 128 completed clinical trials. At present, 53 ongoing studies are being conducted; a majority of these take place in Tampa, FL."

Answered by AI

What illness is Enasidenib Mesylate typically implemented to treat?

"Enasidenib Mesylate is commonly used for invasive procedures, as well as less severe conditions such hypertension, skin disinfection therapy, and benign prostatic hyperplasia (BPH)."

Answered by AI

Recent research and studies

Current Opinion in HematologyJournal

Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission

Shallis, Rory M., and Nikolai A. Podoltsev. 2020. “Maintenance Therapy for Acute Myeloid Leukemia: Sustaining the Pursuit for Sustained Remission”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000637.

clinicaltrials.govStudy

Enasidenib as Maintenance Therapy in Treating Patients With Acute Myeloid Leukemia With IDH2 Mutation After Donor Stem Cell Transplant

2019. "Enasidenib as Maintenance Therapy in Treating Patients With Acute Myeloid Leukemia With IDH2 Mutation After Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03728335.