Myelodysplastic Syndromes study: Olutasidenib
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?
An investigational oral medicine being studied for myelodysplastic syndromes and related conditions.
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
- The study wants to find out if olutasidenib can control these blood conditions and to check how safe the drug is.
- Who it's for
- It is looking for adults who have CCUS, MDS, or CMML.
- What's involved
- Participants will receive the drug and have regular visits and blood tests to monitor their condition and any side effects.
- Time commitment
- The study lasts several months, with multiple clinic visits and blood tests scheduled throughout the treatment period.
- 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
- 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.
- Patients ≥ 18 years old.
You likely can't join if
- 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
- Subject with white blood cell count \> 25 x10\^9/L.
- Note: hydroxyurea use is permitted to meet this criterion with no washout required.
See the full eligibility criteria
- 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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Miami, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.