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New treatment option for Myelodysplastic Syndromes
Official title A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
ClinicalTrials.gov ID: NCT06566742
What this study is testing
What is Olutasidenib?
Olutasidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myelodysplastic syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- To be considered eligible to participate in this study, a patient must meet ALL as follows:
- Pathologically proven CCUS or lower-risk MDS/CMML.
- 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...
- Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revised IPSS...
- Patients must have a documented IDH1 mutation with variant allele frequency (VAF) ≥ 0.02.
You likely can't join if
- To be eligible for entry into the study, the patient must NOT meet any of the exclusion criteria listed below:
- Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the...
- Patients with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric...
- Known active hepatitis B (hepatitis B virus [HBV]) or hepatitis C (hepatitis C virus [HCV]) or HIV infection.
- Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male patients not using highly effective...
- Subject with white blood cell count \> 25 x10\^9/L.
See the full eligibility criteria
- To be considered eligible to participate in this study, a patient must meet ALL as follows:
- Pathologically proven CCUS or lower-risk MDS/CMML.
- 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...
- 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...
- Patients must have a documented IDH1 mutation with variant allele frequency (VAF) ≥ 0.02.
- Patients ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A)
- Acceptable liver function
- Bilirubin ≤ 2 times upper limit of normal (ULN) or ≤ 3 times ULN in patients with Gilbert Syndrome.
- Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤ 3 times ULN.
- 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...
- Negative serum or urine pregnancy test if female of childbearing potential.
- 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...
- 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.
- Ability and willingness to signed informed consent prior to beginning study and undergoing procedures.
- To be eligible for entry into the study, the patient must NOT meet any of the exclusion criteria listed below:
- Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption.
- 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...
- Known active hepatitis B (hepatitis B virus [HBV]) or hepatitis C (hepatitis C virus [HCV]) or HIV infection.
- 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.
- Subject with white blood cell count \> 25 x10\^9/L.
- Note: hydroxyurea use is permitted to meet this criterion with no washout required.
- Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.