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)

Completed · Phase 1 · Has a placebo group

Conditions studied: Graft-Versus-Host Disease

In brief

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.

Key facts

Study ID

NCT00806208

Run by

MedImmune LLC

People needed

34

Starts

1999-01-01

Expected to finish

2000-03-01

Last updated by the study team

2008-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University Medical Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Baylor Institute of Transplant Sciences — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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