Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1 (NCT05030441) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1
United States20 participantsStarted 2022-04-01
Plain-language summary
This is an open-label, multicenter study exploring the efficacy of ivosidenib in patients with clonal cytopenia of undetermined significance (CCUS) with mutations in IDH1. The purpose is to establish proof of principle that ivosidenib is well-tolerated and potentially efficacious in improving blood count abnormalities in these patients.
The study will also be offered in a decentralized, remote structure to patients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:
* Hgb \<10 g/dL
* ANC \<1.8 × 10\^9/L
* Platelets \<100 × 10\^9/L
* IDH1 gene mutation (R132) confirmed by droplet digital PCR (ddPCR) testing, at a frequency \> 2%. This will be performed locally and confirmed at Washington University.
* At least 18 years of age.
* ECOG performance status 0-2
* Adequate organ function as defined below:
* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Serum total bilirubin \< 1.5 x IULN (an upper limit of bilirubin 5mg/dL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)
* Serum creatinine \< 2 x IULN or creatinine clearance \> 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation
* The effects of ivosidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (defined in Section 5.5) prior to study entry, for the duration of study participation, and for 90 days after the last dose of ivosidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 90 days after the last dose of ivosidenib.
* Ability to understand and w…
What they're measuring
1
Rate of improvement in hematologic parameters
Timeframe: Through 30 days after completion of treatment (estimated to be 61 months)