Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.
Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years. Participants will be regularly monitored for toxicities, adverse events, quality of life (QOL), and disease status. Once off treatment, participants will continue to be followed for a maximum of 2 years from date of enrollment for survival endpoints
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Twice daily olutasidenib maintenance therapy
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGAssess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML.
Feasibility defined as the number of participants with 75% protocol treatment compliance for a duration of at least 4 cycles (to include protocol defined dose delays), or until disease relapse or allogeneic hematopoietic stem cell transplant (alloHCT).
Time frame: Up to 2 years
Assess the tolerability of olutasidenib after upfront AML therapy with intensive induction and/or consolidation in IDH1 mutant AML
Incidence of grade ≥4 adverse events (AEs) attributable to study drug for duration of treatment on study
Time frame: Up to 2 years
Measure progression free survival
Progression free survival (PFS), defined as the time from the date of the first dose of study treatment to the date of relapse or death
Time frame: Up to 2 years following end of treatment
Estimate overall survival (OS)
Overall survival defined as the time from the date of diagnosis to the date of death.
Time frame: Up to 2 years following end of treatment
Assess mean residual disease (MRD) negativity rates by both PCR based and flow cytometric methodologies
MRD status by multi-parameter flow cytometry at 10-5 sensitivity, by PCR based IDH1 sequencing assay, or by both methods of detection.
Time frame: Baseline, Cycle 3 Day 15, and End of Treatment (Each cycle is 28 days)
Estimate rates of ability to proceed with transplant given maintenance opportunities.
Incidence of study patients receiving allogeneic hematopoietic stem cell transplant (alloHCT) within 2 years of initiating olutasidenib maintenance therapy.
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Time frame: Up to 2 years
Characterize quality of life (QOL) metrics by SF 36
Health-related quality of life (HRQOL) metrics as assessed by Short Form (SF-36), a 36-item, patient-reported survey that assesses health-related quality of life. This survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The RAND-36 Health Survey is scored by first recoding the answers to a 0-100 scale, with higher scores indicating better health. (https://www.rand.org/health-care/surveys\_tools/mos/36-item-short-form/scoring.html)
Time frame: Cycle 1Day 1, Cycle 2 Day 1, Cycle 4 day 1, and End of Treatment (EOT) (Each cycle is 28 days)