Trial | NCT00035880  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    95
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.
Study Started
Oct 31
1999
Study Completion
Jun 30
2003
Last Update
Jun 24
2005
Estimate

Drug ABX-CBL

Criteria 

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
No Results Posted