Phase II Study of Olutasidenib for Maintenance Therapy in Patients with IDH1-mutated Myeloid Cancers After Stem Cell Transplant

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06668584

Provider View

This study is exploring the safety of using the drug olutasidenib as a maintenance treatment for patients with IDH1-mutated myeloid cancers who have undergone a stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to determine if the drug olutasidenib is safe and well-tolerated when used as a maintenance therapy for patients with IDH1-mutated myeloid cancers after they have received a stem cell transplant. This includes patients with certain types of blood cancers who are in remission after their transplant.

Description

This clinical trial is focused on patients with specific blood cancers that have a mutation in the IDH1 gene. After receiving a stem cell transplant, these patients will be given olutasidenib to see if it can help maintain their remission. The study will monitor the safety and any side effects of the drug.

Participants will be adults aged 18 to 75 who have undergone a stem cell transplant and are in remission. They must have good kidney and liver function, no active infections, and be able to understand and consent to the study. Women of childbearing potential must use effective birth control during the study and for three months after. Men must also agree to use contraception during and for four months after the study.

The study will exclude those who have had certain treatments after their transplant, have severe graft-versus-host disease, or have active infections like HIV or hepatitis. Patients with certain heart conditions or cognitive impairments that could interfere with the study will also be excluded.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific blood cancers like AML, MDS, MPN, or CMML and have had a stem cell transplant.
  • Have an IDH1 gene mutation.
  • Show signs of successful transplant recovery, such as adequate blood cell counts.
  • Be in remission with less than 5% cancer cells in the bone marrow.
  • Aged between 18 and 75 years.
  • Have a performance status that allows for daily activities.
  • Have good kidney function.
  • Have normal liver function tests, except for those with Gilbert's Syndrome.
  • No active bleeding or life-threatening infections.
  • Able to understand the study and provide consent.
  • Women must have a negative pregnancy test and use effective contraception if of childbearing potential.
  • Men and women must agree to use contraception during and after the study.

Exclusion Criteria

  • Have received certain anti-cancer treatments after transplant.
  • Have severe graft-versus-host disease.
  • Have uncontrolled infections, but controlled infections with stable health are allowed.
  • Have active HIV, hepatitis B, or hepatitis C infections, unless well-controlled.
  • Have a heart condition that affects the heart's electrical activity.
  • Have any condition that the study doctor believes would make participation unsafe.
  • Have cognitive or psychiatric issues that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.