Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease
NCT ID: NCT00806728
Last Updated: 2008-12-11
Study Results
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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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
1998-05-31
1998-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MEDI-507
MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
2
MEDI-507
MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.
Interventions
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MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.
Eligibility Criteria
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Inclusion Criteria
* Acute GVHD of at least grade II severity
* Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
* Evidence of engraftment (ANC over 1000 cells/mm3)
* Histologic evidence of GVHD from biopsy performed during the current episode
* Received 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 will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)
Exclusion Criteria
* Clinical or histologic manifestation of chronic GVHD
* Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
* Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
* More than one allogeneic bone marrow or hematopoietic stem cell allograft
* Moribund and unlikely (in the opinion of the investigator) to survive 15 days
* Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
* Any of the following clinical settings or diagnoses:
Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
* Histologically confirmed veno-occlusive disease of the liver
* Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
18 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
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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City of Hope National Medical Center
Duarte, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Washington University Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Hospital-University of Oklahoma
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
South Texas Cancer Institute at Methodist Hospital
San Antonio, Texas, United States
Countries
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Other Identifiers
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MI-CP042
Identifier Type: -
Identifier Source: org_study_id