Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent of the participant and/or legally authorized representative
Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70
Disqualifiers
Patients with more than one allogeneic HCT
History of allergic reactions attributed to compounds of similar chemical or biological composition to study agent
Active diarrhea considered clinically significant and may impair oral drug administration
Clinically significant uncontrolled illness
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Olutasidenib
DrugGiven PO
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment (olutasidenib)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)
AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame
Up to 30 days after last dose of study treatment2
Proportion of patients completing at least 6 months of study therapy
Tolerability will be defined as the proportion of patients who complete at least 6 months of study therapy.
Time frame
Up to 2 yearsSecondary outcomes
1
Overall survival (OS)
OS will be analyzed using the Kaplan-Meier method.
Time frame
From start of treatment to death, assessed up to 2 years2
Leukemia-free survival (LFS)
LFS will be analyzed using the Kaplan-Meier method.
Time frame
From start of treatment to relapse or death, assessed up to 2 years3
Time to relapse
Time to relapse will be analyzed using the curves of cumulative incidence.
Time frame
From start of treatment to relapse, assessed up to 2 years4
Non-relapse mortality (NRM)
NRM will be analyzed using the curves of cumulative incidence.
Time frame
From start of treatment to death from causes other than relapse, assessed up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov