NCT06566742 A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
| NCT ID | NCT06566742 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2024-12-10 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Eligibility Criteria
Inclusion Criteria: To be considered eligible to participate in this study, a patient must meet ALL inclusion criteria as follows: 1. Pathologically proven CCUS or lower-risk MDS/CMML. 1. CCUS is defined as the presence of cytopenia (absolute neutrophil count \< 1.8 x 10\^9/L, hemoglobin \< 13 g/dL in males or \< 12 g/dL in females, and/or platelets \< 150 x 10\^9/L) for at least 30 days that are otherwise unexplained and with no diagnostic hematopathologic features of myeloid neoplasms. Patients with known Duffy-null phenotype must have absolute neutrophil counts less than their lower limit of normal. 2. Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revised IPSS (IPSS-R) score ≤ 3.5 and Molecular IPSS (IPSS-M) very low-, low-, or moderate low-risk categories. 2. Patients must have a documented IDH1 mutation with variant allele frequency (VAF) ≥ 0.02. 3. Patients ≥ 18 years old. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A) 5. Acceptable liver function 1. Bilirubin ≤ 2 times upper limit of normal (ULN) or ≤ 3 times ULN in patients with Gilbert Syndrome. 2. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤ 3 times ULN. 6. Acceptable renal function with serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 50 mL/min (as assessed by Cockcroft-Gault, Modification of Diet in Renal Disease Formula \[MDRD\], or Chronic Kidney Disease Epidemiology \[CKD-Epi\] validated measures). 7. Negative serum or urine pregnancy test if female of childbearing potential. 8. For fertile men and women, agreement to use highly effective contraceptive methods for the duration of study participation and 90 days after the last dose of study medication. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide). 9. Agreement for male patients not to donate sperm and for female patients of childbearing potential not to donate ova during the study and for 90 days after the final dose of study drug. 10. Ability and willingness to signed informed consent prior to beginning study and undergoing procedures. Exclusion Criteria: To be eligible for entry into the study, the patient must NOT meet any of the exclusion criteria listed below: 1. Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption. 2. Patients with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the patient at unacceptable risk of study treatment. 3. Known active hepatitis B (hepatitis B virus \[HBV\]) or hepatitis C (hepatitis C virus \[HCV\]) or HIV infection. 4. Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male patients not using highly effective contraception as defined in the inclusion criteria. 5. Subject with white blood cell count \> 25 x10\^9/L. * Note: hydroxyurea use is permitted to meet this criterion with no washout required. 6. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care.
Contact & Investigator
Kelly Chien, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06566742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06566742 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06566742 currently recruiting?
Yes, NCT06566742 is actively recruiting participants. Contact the research team at kchien@mdanderson.org for enrollment information.
Where is the NCT06566742 trial being conducted?
This trial is being conducted at Miami, United States, Houston, United States.
Who is sponsoring the NCT06566742 clinical trial?
NCT06566742 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Kelly Chien, MD at M.D. Anderson Cancer Center. The trial plans to enroll 15 participants.