Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Part of paid clinical trials in Miami, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06660355
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Graft-versus-host Disease (cGVHD)

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is a Janus kinase inhibitor.
  • Prednisone — DRUG
    Prednisone is a glucocorticoid.

Study Details

Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.

Key Dates

Start date
Dec 23, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Treatment Arm
    Ruxolitinib is administered as 10 mg orally twice daily in 28-day cycles.
  • Active Comparator: Prednisone Treatment Arm
    Prednisone will be started at 1mg/kg/day based on patient current body weight in kilograms.

Primary Outcome Measure

Treatment Success [ Time Frame: 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Univ of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Noa Holtzman, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Farhad Khimani, MD (PRINCIPAL_INVESTIGATOR)
Melissa Alsina, MD (SUB_INVESTIGATOR)
Nelli Bejanyan, MD (SUB_INVESTIGATOR)
Omar Castaneda Puglianini, MD (SUB_INVESTIGATOR)
Hany Elmariah, MD (SUB_INVESTIGATOR)
Rawan Faramand, MD (SUB_INVESTIGATOR)
Ciara Freeman, MD, PhD (SUB_INVESTIGATOR)
Doris Hansen, MD (SUB_INVESTIGATOR)
Michael Jain, MD, PhD (SUB_INVESTIGATOR)
Aleksandr Lazaryan, MD, PhD (SUB_INVESTIGATOR)
Hien Liu, MD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Sayeef Mirza, MD (SUB_INVESTIGATOR)
Asmita Mishra, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Jose Ochoa-Bayona, MD (SUB_INVESTIGATOR)
Lia Perez, MD (SUB_INVESTIGATOR)
Fabiana Perna, MD, PhD (SUB_INVESTIGATOR)
Joseph Pidala, MD, PhD (SUB_INVESTIGATOR)
University of Kansas Cancer CenterKansas CityKansas66160
Muhammad Umair Mushtaq, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22908
Indumathy Varadarajan, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23219
William Clark, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Univ of Miami - Sylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLUniversity of Kansas Cancer Center· Kansas City, KSUniversity of Virginia Comprehensive Cancer Center· Charlottesville, VAVirginia Commonwealth University· Richmond, VA

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