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Clinical trialNCT06660355RecruitingPhase 2Interventional

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

SponsorH. Lee Moffitt Cancer Center and Research InstituteEnrollment120Chronic Graft-versus-host Disease (cGVHD)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Univ of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, United States

    Noa Holtzman, MD
    Recruiting
  • Moffitt Cancer Center

    Tampa, Florida, United States

    Aleksandr Lazaryan, MD, PhDAsmita Mishra, MDCiara Freeman, MD, PhDDoris Hansen, MDFabiana Perna, MD, PhDFarhad Khimani, MDFrederick Locke, MDHany Elmariah, MDHien Liu, MDJose Ochoa-Bayona, MDJoseph Pidala, MD, PhDLia Perez, MDMelissa Alsina, MDMichael Jain, MD, PhDNelli Bejanyan, MDOmar Castaneda Puglianini, MDRawan Faramand, MDSayeef Mirza, MDTaiga Nishihori, MD
    Recruiting
  • University of Kansas Cancer Center

    Kansas City, Kansas, United States

    Muhammad Umair Mushtaq, MD
    Recruiting
  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, United States

    Alexander Vartanov, MD
    Recruiting
  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, United States

    Indumathy Varadarajan, MD
    Recruiting
  • Virginia Commonwealth University

    Richmond, Virginia, United States

    William Clark, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
23 Dec 2024
Primary completion
31 Dec 2028
Completion
31 Dec 2028
Last update posted
5 Aug 2026
Registered enrollment
120
Registry id
NCT06660355

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.