Status:
COMPLETED
Trial for Evaluation of Safety of Escalating Dose Levels of MEDI-507 in Patients for Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)
Lead Sponsor:
MedImmune LLC
Conditions:
Graft-Versus-Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.
Detailed Description
The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marr...
Eligibility Criteria
Inclusion
- allogeneic bone marrow or hematopoietic stem cell graft recipients
- acute GvHD of at least Grade II severity
- receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
- evidence of engraftment (ANC over 1,000 cells/mm3)
- histologic evidence of GvHD from biopsy performed during the current episode
- receipt of GvHD prophylaxis of methotrexate, tacrolimus or cyclosporine
- age at least 18 years
- body weight under 130 kg
- Both males and females are eligible, but females of childbearing potential, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant7 or DepoProvera7) beginning with the first study injection and continuing through 60 days after the final study injection.
Exclusion
- previous receipt of MEDI 507
- diagnosis of chronic GvHD
- previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
- receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
- treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
- intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent)
- more than one allogeneic bone marrow or hematopoietic stem cell allograft
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2000
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00806208
Start Date
January 1 1999
End Date
March 1 2000
Last Update
December 11 2008
Active Locations (3)
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1
Washington University Medical Center
St Louis, Missouri, United States, 63110
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
3
Baylor Institute of Transplant Sciences
Dallas, Texas, United States, 75246