Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion (NCT03722407) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion
United States29 participantsStarted 2019-08-28
Plain-language summary
This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML)using the World Health Organization (WHO) classification.
* 18 years of age or older at the time of obtaining informed consent.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Participants must be able to provide adequate BM aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure.
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 is required.
* Women of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
* Must understand and voluntarily sign an informed consent form.
* Must have a life expectancy of greater than 3 months at time of screening.
* Must have symptomatic splenomegaly and/or an Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score \>17.
Exclusion Criteria:
* Any of the following lab abnormalities: Platelet count of less than 35,000/uL, Absolute Neutrophil Count (ANC) less than 250/uL, Serum Creatinine ≥ 2.0, Serum total bilirubin \>1.5x ULN
* Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the trea…
What they're measuring
1
Overall Response
Timeframe: At week 16
Trial details
NCT IDNCT03722407
SponsorH. Lee Moffitt Cancer Center and Research Institute