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NCT00035880 Clinical Trial

Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease

Graft Vs Host Disease Clinical Trial

Official title:
A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial Evaluating ABX-CBL When Compared to Atgam as Second Line Therapy in Patients With Steroid Resistant Acute Graft Versus Host Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035880
Other study ID # ABX-CB-9906
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 6, 2002
Last updated June 23, 2005
Start date October 1999
Est. completion date June 2003

Study information
Verified date July 2003
Source Abgenix
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.

Other known NCT identifiers
  • NCT00012077

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility Inclusion Criteria:

- Recipient of single allogeneic stem cell transplant from any donor type

- Time post transplant less than 100 days

- Received no treatment for GVHD other than steroids

Exclusion Criteria:

- Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant

- IBMTR index less than A

- Received any murine product in the past

- Diagnosed with chronic GVHD

- Received Atgam later than day 10 post transplant

- Change to prophylactic regimen for acute GVHD within 72 hours of randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABX-CBL

Locations
Country Name City State
United States Abgenix, Inc Fremont California

Sponsors (2)
Lead Sponsor Collaborator
Abgenix Sangstat Medical Corporation

Country where clinical trial is conducted

United States, 

See also
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