RecruitingMyeloid Malignancies
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 1. Diagnosis of AML, MDS, MPN, or CMML according to World Health Organization (WHO) classification that underwent first or second alloSCT regardless of stem cell source, 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)).
You may not qualify if…
- ✕ 1. Use of any of the following after transplantation and prior to starting study therapy. Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous, or oral 5-azacitidine or FL T3 inhibitors for maintenance)
- ✕ 2. Overall grade II-IV aGVHD. However, upon complete resolution of aGVHD-related symptoms with grade 1 or 0 overall clinical grade would be appropriate to enroll at that time. Patients may be eligible for enrollment if they are on prednisone 0.5 mg/kg daily dose or lower, tacrolimus, sirolimus, and/or ruxolitinib.
- ✕ 3. cGVHD, moderate or servere by NIH criteria.
- ✕ 4. Active uncontrolled systemic fungal, bacterial, or viral infection. However, patients receiving anti-micobial agents including antibiotics, antiviral and antifungal therapies are allowed if the infection is controlled, and the patient is hemodynamically stable.
- ✕ 5. Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
- ✕ Patients with known active hepatitis B virus (HBV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy that is not contraindicated in this study, then they would be eligible for study.
- ✕ Patients with known active hepatitis C virus (HCV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient with a history of HCV infection has received definitive therapy (and is now HCV viral load negative), or if a patient has a reactive HCV antibody test but has an undetectable viral load by PCR, then they would be eligible.
- ✕ Patients with known active HIV infection will be excluded out of concern for the drug-drug interaction with venetoclax and highly active antiretroviral therapy (HART)
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT06668584 · last updated 2026-08-19