Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03722407
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib 5 mg tablets, 4 per dose

Study Details

This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.

Key Dates

Start date
Aug 28, 2019
Status verified
Mar 2026
Primary completion
Sep 19, 2022
Completion
Jun 1, 2026

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.

Primary Outcome Measure

Overall Response [ Time Frame: At week 16 ]

Locations (5)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
Cleveland ClinicClevelandOhio44195-

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