Campath-1H + FK506 and Methylprednisolone for GVHD

Phase 2

Completed

• Conditions: 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

• Registration Number: NCT00109993
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-05-03
• Study First Submitted QC: 2005-05-03
• Study First Posted: 2005-05-04
• Primary Completion: 2006-06
• Study Completion: 2007-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Graft-vs-host disease response	1, 2, 3, and 4 months

Secondary Outcome Measures

Name	Time	Method
Incidence of serious infections by clinical, radiologic, and microbiologic assessments	1,2,3, and 4 months

Trial Locations

Locations (6)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Mt. Sinai Medical Center; 🇺🇸 New York, New York, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Texas Transplant Institute; 🇺🇸 San Antonio, Texas, United States

Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States