Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 2

Completed

• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
• Interventions: Biological: alemtuzumab; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: melphalan; Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

• Registration Number: NCT00027560
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.

Detailed Description

OBJECTIVES:

Overall survival-12 months

Overall survival-24 months

Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant

Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant

Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant

Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years post transplant

* OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched) (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).

Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0.

Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100.

Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated.

PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched related or matched unrelated donor stratum closed to accrual as of 1/11/06).

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2001-12-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2012-11-27
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Results First Posted: 2013-01-07
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	alemtuzumab	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	fludarabine phosphate	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	allogeneic bone marrow transplantation	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	peripheral blood stem cell transplantation	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	melphalan	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES	cyclosporine	This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.

Primary Outcome Measures

Name	Time	Method
Overall Survival	24 months post transplant
Acute Graft-versus-Host Disease Matched Related Patients	up to 4 months post transplant	Grade III-IV Acute Graft-versus-Host Disease

Secondary Outcome Measures

Name	Time	Method
Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients	up to 4 months post transplant	Grade III-IV Acute Graft-versus-Host Disease
Extensive Chronic Graft-versus-Host Disease Matched Related Patients	up to 2 years post transplant
Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients	up to 2 years post transplant

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States