Rituximab for GVHD

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT00578591
Phase
PHASE2
Status
Withdrawn

Conditions

  • Alogenic Hematopoietic Transplant
  • Graft vs Host Disease

Eligibility Criteria

Sex
ALL
Age
N/A - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 is given weekly X 4. For patients with a partial response, an additional 4 doses will be permitted as needed (after 4 weeks from the last dose). Diagnosis of grade II to IV aGVHD will be confirmed, whenever possible, by a biopsy taken from at least one of the following three sites: skin, gut, or liver.

Study Details

This is a prospective, open-label pilot study in which 4 doses of Rituximab are administered to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT). The study is designed to determine the overall survival at 180 days after treatment with rituximab, and evaluates the safety and clinical response to rituximab in this study population. Study entry: Patients must enter study on or before day +100 posttransplant.

Key Dates

Start date
Jun 30, 2007
Status verified
Jul 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patient
    Four Rituximab doses administered to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT)

Primary Outcome Measure

Complete response rate at 4 and 8 weeks in patients with SR-GVHD treated with Rituximab. [ Time Frame: 2 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Methodist HospitalHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-

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