RECRUITING

A Phase 2 Study Evaluating Olutasidenib in Combination with Hypomethylating Agents in Patients with IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

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Conditions

Chronic Myelomonocytic LeukemiaAdvanced Myeloproliferative NeoplasmsIDH1-mutated Higher-Risk Myelodysplastic Syndromes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.

Official Title

A Phase 2 Study Evaluating Olutasidenib in Combination with Hypomethylating Agents in Patients with IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm

Quick Facts

Study Start:2025-01-28
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06597734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pathologically proven higher-risk MDS/CMML or advanced MPN
  2. 1. MDS/CMML participants must have International Prognostic Scoring System (IPSS) intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score \> 3.5 or Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or bone marrow blast percentage.
  3. 2. Advanced MPN is defined as bone marrow blast percentage \>/=10%.
  4. 3. Participants on the treatment-naive arm must not have received a prior HMA. Agents such as growth factors (e.g. erythropoietin stimulating agents, luspatercept, eltrombopag, granulocyte colony stimulating factors), cyclosporine, and/or hydroxyurea are allowed.
  5. 2. Participants must have a documented IDH1 mutation
  6. 3. Participants \>/= 18 years old
  7. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A)
  8. 5. Acceptable liver function
  9. 1. Bilirubin \</= 2 times upper limit of normal (ULN) or \</= 3 times ULN in participants with Gilbert Syndrome
  10. 2. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase \</= 3 times ULN
  11. 6. Acceptable renal function with serum creatinine \</= 1.5 times ULN or calculated creatinine clearance \>/= 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or CKD-Epi validated measures)
  12. 7. Negative serum or urine pregnancy test if female of childbearing potential
  13. 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
  14. 9. Agreement for male participants not to donate sperm and for female participants of childbearing potential not to donate ova during the study and for 90 days after the final dose of study drug
  15. 10. Ability and willingness to sign informed consent prior to beginning study and undergoing procedures
  1. 1. Participants unable to swallow oral medications, or participants with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption
  2. 2. Participants with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the participant at unacceptable risk of study treatment
  3. 3. Known active hepatitis B (HBV) or hepatitis C (HCV) or HIV infection
  4. 4. Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male participants not using highly effective contraception
  5. 5. Participants with white blood cell count \> 25 x109/L Note: hydroxyurea use is permitted to meet this criterion
  6. 6. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care

Contacts and Locations

Study Contact

Kelly Chien, MD
CONTACT
713-745-7584
Kchien@mdanderson.org

Principal Investigator

Kelly Chien, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Kelly Chien, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-28
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2029-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Myelomonocytic Leukemia
  • Advanced Myeloproliferative Neoplasms
  • IDH1-mutated Higher-Risk Myelodysplastic Syndromes