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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)

NCT ID: NCT00806208

Last Updated: 2008-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2000-03-31

Brief Summary

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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

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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.

Conditions

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Graft-Versus-Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MEDI 507 and Methylprednisolone

Group Type ACTIVE_COMPARATOR

MEDI-507

Intervention Type DRUG

0.012 mg/kg MEDI 507 and Methylprednisolone

2

MEDI-507 and Methylprednisolone

Group Type ACTIVE_COMPARATOR

MEDI-507

Intervention Type DRUG

0.04 mg/kg MEDI 507 and Methylprednisolone

3

MEDI-507 and Methylprednisolone

Group Type ACTIVE_COMPARATOR

MEDI-507

Intervention Type DRUG

0.12 mg/kg MEDI 507 and Methylprednisolone

4

MEDI-507 and Methylprednisolone

Group Type ACTIVE_COMPARATOR

MEDI-507

Intervention Type DRUG

0.4 mg/kg MEDI 507 and Methylprednisolone

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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MEDI-507

0.012 mg/kg MEDI 507 and Methylprednisolone

Intervention Type DRUG

MEDI-507

0.04 mg/kg MEDI 507 and Methylprednisolone

Intervention Type DRUG

MEDI-507

0.12 mg/kg MEDI 507 and Methylprednisolone

Intervention Type DRUG

MEDI-507

0.4 mg/kg MEDI 507 and Methylprednisolone

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. allogeneic bone marrow or hematopoietic stem cell graft recipients
2. acute GvHD of at least Grade II severity
3. receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
4. evidence of engraftment (ANC over 1,000 cells/mm3)
5. histologic evidence of GvHD from biopsy performed during the current episode
6. receipt of GvHD prophylaxis of methotrexate, tacrolimus or cyclosporine
7. age at least 18 years
8. body weight under 130 kg
9. 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

1. previous receipt of MEDI 507
2. diagnosis of chronic GvHD
3. previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
4. receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
5. treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
6. 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)
7. more than one allogeneic bone marrow or hematopoietic stem cell allograft
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Medimmune Inc.

Principal Investigators

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J. Bruce McClain, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Washington University Medical Center

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Baylor Institute of Transplant Sciences

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MI-CP046

Identifier Type: -

Identifier Source: org_study_id