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Trial Title:
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients with IDH1-mutated Myeloid Malignancies
NCT ID:
NCT06668584
Condition:
Myeloid Malignancies
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olutasidenib
Description:
Given by mouth
Arm group label:
Olutasidenib Maintenance Therapy
Summary:
The goal of this clinical research study is to learn about the safety and tolerability of
giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance
therapy after they receive a stem cell transplant.
Detailed description:
Primary Objective:
The goal of this clinical research study is to learn about the safety and tolerability of
giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance
therapy after they receive a stem cell transplant.
Secondary Objectives:
The goal of this clinical research study is to learn about the safety and tolerability of
giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance
therapy after they receive a stem cell transplant.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of AML, MDS, MPN, CMML according to World Health Organization (WHO)
classification that underwent first or second alloSCT with either peripheral blood
or bone marrow hematopoietic stem cell source, regardless of donor type/match,
conditioning regimen, or GVHD prophylaxis and is at least 30 days post stem cell
transplant until day 120.
2. Evdence of an IDH1 mutation presence by next generation sequencing panel at original
diagnosis.
3. Evidence of engraftment by Absolute neutrophil count (ANC) >/= 1.0x 109/L without
daily use of myeloid growth factor (G-CSF) for at least 7 days; and Platelet >/= 30
x 109/L with out platelet transfusion within 1 week.
4. Patient in morphologic remission with Day +30 bone marrow <5% blast. Will include
MRD positive or negative.
5. Age 18 to 75 years old.
6. ECOG performance status of 0, 1, 2. Or KPS above 70.
7. Creatinine clearance greater or equal to 40cc/min as defined by the Cockcroft-Gault
Equation.
Males (mL/min): (140-age) *IBW (kg) / 72*(serum creatinine(mg/dl)) Females (mL/min):
0.85*(140-age) *IBW (kg) / 72*(serum creatinine(mg/dl)).
8. Serum bilirubin 480 milliseconds.
7. Any other condition that would, in the Investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns with clinical
study procedures.
8. Patients with cognitive impairments or psychiatric disorders that can interfere with
safety or with obtaining informed consent of compliance with study procedures.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas M. D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Jeremy Ramdial, MD
Phone:
(713) 745-0146
Email:
jlramdial@mdanderson.org
Contact backup:
Last name:
Jeremy Ramdial, MD
Start date:
December 31, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06668584
http://www.mdanderson.org
