Campath-1H + FK506 and Methylprednisolone for GVHD
RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.
PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Graft Versus Host Disease
Multiple Myeloma and Plasma Cell Neoplasm
Testicular Germ Cell Tumor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease|
- Graft-vs-host disease response [ Time Frame: 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]
- Incidence of serious infections by clinical, radiologic, and microbiologic assessments [ Time Frame: 1,2,3, and 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||May 2007|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
- Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.
- Determine the best response at 4 and 12 weeks in patients treated with this regimen.
- Determine 6-month survival of patients treated with this regimen.
- Determine the rate of infectious complications in patients treated with this regimen.
- Determine rate of chronic GVHD in patients treated with this regimen.
OUTLINE: This is an open-label, single-blind, multicenter study.
Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.
After completion of study treatment, patients are followed at 2 and 4 weeks.
PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109993
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-7284|
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Western Pennsylvania Hospital|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Texas|
|Texas Transplant Institute|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Mary Laughlin, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|