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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118352 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor 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 and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and best dose of alemtuzumab when given together with fludarabine and total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: alemtuzumab Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Campath® (Alemtuzumab) Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class II Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies: A Multicenter Trial |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of alemtuzumab.
Nonmyeloablative conditioning regimen: Patients receive alemtuzumab* IV over 6 hours once daily on days -6 to
NOTE: *The first cohort of patients do not receive alemtuzumab.
After completion of study transplantation, patients are followed periodically for 3 months, at 6, 12, and 18 months, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 25-100 patients will be accrued for this study.
Ages Eligible for Study: | up to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Aggressive non-Hodgkin's lymphoma (NHL), including, but not limited to, diffuse large B-cell NHL, meeting 1 of the following criteria:
Low-grade NHL
Mantle cell NHL
Chronic lymphocytic lymphoma, meeting both of the following criteria:
Hodgkin's lymphoma, meeting both of the following criteria:
Multiple myeloma, meeting 1 of the following criteria:
Acute myeloid leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia
Myelodysplastic syndromes or myeloproliferative diseases, meeting both of the following criteria:
Waldenstrom Macroglobulinemia
Disease treatable by HSCT
Related or unrelated donor available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No active non-hematologic malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Colorado | |
Rocky Mountain Cancer Centers - Denver Midtown | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Michael B. Maris, MD 303-388-4876 | |
United States, Utah | |
LDS Hospital | Recruiting |
Salt Lake City, Utah, United States, 84143 | |
Contact: Finn B. Petersen, MD 801-408-1818 ldfpeter@ihc.com | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Brenda Sandmaier, MD 206-667-4961 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
Veterans Affairs Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Thomas R. Chauncey, MD, PhD 206-764-2709 | |
Italy | |
Universita di Torino | Recruiting |
Turin, Italy, 10126 | |
Contact: Benedetto Bruno, MD, PhD 39-0339-112-9064 |
Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Brenda Sandmaier ) |
Study ID Numbers: | CDR0000430704, FHCRC-1959.00 |
Study First Received: | July 8, 2005 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00118352 History of Changes |
Health Authority: | Unspecified |
noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma recurrent adult Hodgkin lymphoma recurrent adult Burkitt lymphoma stage III adult Burkitt lymphoma |
stage IV adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma |
Anti-Infective Agents Chronic Myelomonocytic Leukemia Cyclosporine Lymphoma, Mantle-Cell Mycophenolic Acid Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Mycophenolate mofetil |
Neoplasm Metastasis Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myeloproliferative Disorders Juvenile Myelomonocytic Leukemia Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia B-cell Lymphomas |
Anti-Infective Agents Cyclosporine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Mycophenolic Acid Cyclosporins Preleukemia Hemorrhagic Disorders Pathologic Processes Alemtuzumab Therapeutic Uses Mycophenolate mofetil Cardiovascular Diseases Dermatologic Agents |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Multiple Myeloma Neoplasms Fludarabine Lymphoma, Non-Hodgkin Antimetabolites Precancerous Conditions Immunologic Factors Blood Protein Disorders Antineoplastic Agents Paraproteinemias Antibiotics, Antineoplastic |