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IDH1 Inhibitor

Olutasidenib for Leukemia

Phase 1

Recruiting

Led By Amandeep Salhotra, MD

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

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70

Must not have

Pregnant or breastfeeding females

Active clinically significant diarrhea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing olutasidenib, a medication that belongs to a class of drugs called IDH1 inhibitors, to see if it is safe and effective in preventing the return of disease in patients

Who is the study for?

This trial is for patients with IDH1 mutated AML, MDS, or CMML who have had a donor hematopoietic cell transplant. It's designed to see if the drug olutasidenib can prevent their disease from coming back.

What is being tested?

The trial is testing the safety and effectiveness of olutasidenib, an IDH1 inhibitor that aims to slow down or stop cancer cells from growing. This phase I trial will determine if it's safe and tolerable for preventing relapse after transplant.

What are the potential side effects?

Possible side effects of olutasidenib may include but are not limited to gastrointestinal symptoms, changes in blood counts, fatigue, liver enzyme alterations, and potential risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am mostly able to care for myself and remain up and about.

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My leukemia diagnosis includes mIDH1.

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I am scheduled for or have had a stem cell transplant from a donor.

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My bone marrow test after transplant shows less than 5% cancer cells.

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I have been treated with IDH1 inhibitors before.

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 experiencing severe diarrhea.

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I have a serious illness that is not under control.

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I have had more than one bone marrow transplant from a donor.

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I do not have active hepatitis B, C, or HIV.

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I have no active cancer except for non-melanoma skin cancer or cervical cancer in-situ.

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I have a moderate to severe form of acute graft-versus-host disease.

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I am currently on medication for an uncontrolled infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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)

Proportion of patients completing at least 6 months of study therapy

Secondary study objectives

Graft versus host disease (GVHD) free, relapse-free survival (GRFS)

Incidence of chronic GVHD (cGVHD)

Leukemia-free survival (LFS)

+4 more

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 (olutasidenib)Experimental Treatment2 Interventions

Starting 50-120 days after transplant, patients receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 14Eligibility criteria met