Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Graft-vs-host disease response
1, 2, 3, and 4 months
No
Mary Laughlin, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE1Z04
NCT00109993
January 2005
May 2007
Name | Location |
|---|---|
| Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Oregon Health Sciences University | Portland, Oregon |
| Texas Transplant Institute | San Antonio, Texas 78229 |
| Mt. Sinai Medical Center | New York, New York 10029 |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
