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)

NCT00806208 | Completed Phase 1

• 1 other identifier: MI-CP046
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Safety; first infusion of study drug

  Through Study Day 44

Study Arms (5)

1

ACTIVE COMPARATOR

MEDI 507 and Methylprednisolone

Drug: MEDI-507

2

ACTIVE COMPARATOR

MEDI-507 and Methylprednisolone

Drug: MEDI-507

3

ACTIVE COMPARATOR

MEDI-507 and Methylprednisolone

Drug: MEDI-507

4

ACTIVE COMPARATOR

MEDI-507 and Methylprednisolone

Drug: MEDI-507

5

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MEDI-507 DRUG

0.012 mg/kg MEDI 507 and Methylprednisolone

1

Placebo OTHER

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

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Baylor Institute of Transplant Sciences

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• J. Bruce McClain, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: January 1, 1999
• Primary Completion: January 1, 2000
• Study Completion: March 1, 2000
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

US (3)