Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT06046248
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Belumosudil — DRUG
    200mg PO QD x 24 cycles (28-day cycle)
  • Rituximab — DRUG
    375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses

Study Details

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Key Dates

Start date
Jan 29, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belumosudil Plus Rituximab
    Belumosudil plus Rituximab

Primary Outcome Measure

Number of patients who achieve partial and complete responses after treatment [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342
Caitlin Guzowski, MBA, MHA
404-851-8523
H. Kent Holland, MD (SUB_INVESTIGATOR)
Asad Bashey, MD (SUB_INVESTIGATOR)
Lawrence E Morris, MD (SUB_INVESTIGATOR)
Scott Solomon, MD (PRINCIPAL_INVESTIGATOR)
Melhem Solh, MD (SUB_INVESTIGATOR)
Lizamarie Bachier-Rodriguez, MD (SUB_INVESTIGATOR)

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