Study:
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor |
Biological: alemtuzumab Drug: methylprednisolone Drug: tacrolimus |
Phase 2 |
Verified by
Case Comprehensive Cancer Center
June, 2010
Sponsored by: Case Comprehensive Cancer Center
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT00109993
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
Mary Laughlin, MD., Principal Investigator