Campath-1H + FK506 and Methylprednisolone for GVHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00109993|
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||May 2007|
- Biological: alemtuzumab
alemtuzumab IV over 2 hours on days 4-6, 18, and 32
- Drug: methylprednisolone
methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
- Drug: tacrolimus
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
- Graft-vs-host disease response [ Time Frame: 1, 2, 3, and 4 months ]
- Incidence of serious infections by clinical, radiologic, and microbiologic assessments [ Time Frame: 1,2,3, and 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109993
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-7284|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|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|