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)

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University Medical Center, St Louis, Missouri, United States

About this study

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 marrow allograft recipients.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

MEDI-507

Drug

0.012 mg/kg MEDI 507 and Methylprednisolone

Placebo

Other

Placebo IV (alternative) study days 0, 3,6, and 9

Primary outcomes

Safety; first infusion of study drug

Time frame: Through Study Day 44

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

Important dates

Study start: 1999
Primary completion: 2000
Study completion: 2000
First posted: Dec 10, 2008
Registry last updated: Dec 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed