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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047060 |
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Allogeneic peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the anticancer therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and cyclosporine may prevent this rejection.
PURPOSE: This phase I/II trial is studying how well giving alemtuzumab together with chemotherapy and donor peripheral stem cell transplantation works in treating patients with advanced mycosis fungoides and/or Sezary syndrome.
Condition | Intervention | Phase |
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Lymphoma |
Drug: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study Of HLA-Matched Mobilized Peripheral Blood Hematopoetic Stem Cell Transplantation For Advanced Mycosis Fungoides/Sezary Using NonMyeloablative Conditioning With Campath-1H |
Estimated Enrollment: | 58 |
Study Start Date: | July 2002 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Regimen A: Experimental
Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15 and fludarabine IV over 30 minutes on days -5 to -1.
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Drug: alemtuzumab
Given IV
Drug: fludarabine phosphate
Given IV
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Regimen B: Experimental
Patients receive alemtuzumab IV over 2 hours on days -28, -27, -26, -24, -22, -19, -17, and -15; fludarabine IV over 30 minutes on days -5 to -1; and cyclophosphamide IV over 1 hour on days -7 and -6.
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Drug: alemtuzumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
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OBJECTIVES:
OUTLINE: Patients receive 1 of 2 nonmyeloablative conditioning regimens, depending on engraftment efficacy in prior patients.
Patients also receive graft-versus-host disease prophylaxis comprising oral cyclosporine twice a day beginning on day -4 and continuing until day 100.
Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
Donor T cell and myeloid chimerism will be evaluated and will guide decisions regarding donor lymphocyte infusions.
Patients are followed every 2 months for 6 months, every 3 months for 1.5 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 9-58 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed mycosis fungoides (MF)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Patient Recruitment 800-411-1222 |
Study Chair: | Ramaprasad Srinivasan, MD | National Heart, Lung, and Blood Institute (NHLBI) |
Responsible Party: | National Heart, Lung, and Blood Institute ( Ramaprasad Srinivasan ) |
Study ID Numbers: | CDR0000257524, NHLBI-02-H-0250 |
Study First Received: | October 3, 2002 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00047060 |
Health Authority: | Unspecified |
recurrent mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Sezary Syndrome Fludarabine monophosphate Cyclophosphamide Mycosis Fungoides Recurrence Mycoses |
Lymphatic Diseases Alemtuzumab Lymphoma, T-Cell Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |