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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)

Primary Purpose

Graft-Versus-Host Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MEDI-507

Placebo

About this trial

This is an interventional treatment trial for Graft-Versus-Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Washington University Medical Center
University of Nebraska Medical Center
Baylor Institute of Transplant Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

MEDI 507 and Methylprednisolone

MEDI-507 and Methylprednisolone

Placebo

Outcomes

Primary Outcome Measures

Safety; first infusion of study drug

Secondary Outcome Measures

Full Information

NCT ID

NCT00806208

First Posted

December 9, 2008

Last Updated

December 10, 2008

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT00806208

Brief Title

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)

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

January 1999 (undefined)

Primary Completion Date

January 2000 (Actual)

Study Completion Date

March 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MedImmune LLC

4. Oversight

5. Study Description

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 marrow allograft recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft-Versus-Host Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

MEDI 507 and Methylprednisolone

Arm Title

Arm Type

Active Comparator

Arm Description

MEDI-507 and Methylprednisolone

Arm Title

Arm Type

Active Comparator

Arm Description

MEDI-507 and Methylprednisolone

Arm Title

Arm Type

Active Comparator

Arm Description

MEDI-507 and Methylprednisolone

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.012 mg/kg MEDI 507 and Methylprednisolone

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.04 mg/kg MEDI 507 and Methylprednisolone

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.12 mg/kg MEDI 507 and Methylprednisolone

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.4 mg/kg MEDI 507 and Methylprednisolone

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety; first infusion of study drug

Time Frame

Through Study Day 44

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Bruce McClain, M.D.

Organizational Affiliation

MedImmune LLC

Official's Role

Study Director

Facility Information:

Facility Name

Washington University Medical Center

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

Baylor Institute of Transplant Sciences

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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)

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