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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075478 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, 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 cells 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. It is not yet known whether total-body irradiation followed by donor stem cell transplant is more effective with or without fludarabine in treating hematologic cancer.
PURPOSE: This randomized phase III trial is studying total-body irradiation and fludarabine to see how it works compared with total-body irradiation alone followed by donor stem cell transplant in treating patients with hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: fludarabine phosphate Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Multi-Center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus Fludarabine/TBI for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Conditioning arm I: Experimental
Patients receive fludarabine IV on days -4 to -2. Patients then undergo low-dose total body irradiation (TBI) on day 0.
|
Drug: fludarabine phosphate
Given IV
Radiation: radiation therapy
Patients undergo low-dose total body irradiation on day 0
|
|
Conditioning arm II: Experimental
Patients undergo low-dose TBI on day 0.
|
Radiation: radiation therapy
Patients undergo low-dose total body irradiation on day 0
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease risk (indolent vs aggressive), and prior conventional hematopoietic stem cell transplantation (yes vs no).
Nonmyeloablative conditioning regimen: Patients are randomized to 1 of 2 treatment arms.
Patients are followed periodically for 1.5 years and then annually for 5 years post-transplantation.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic malignancy treatable with hematopoietic stem cell transplantation (HSCT) OR a B-cell malignancy, including any of the following:
Aggressive non-Hodgkin's lymphoma (NHL) and other histologies, such as diffuse large B-cell non-Hodgkin's lymphoma (NHL)
Mantle cell lymphoma
Chronic lymphocytic leukemia
Meets 1 of the following criteria:
Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia
Myelodysplastic syndromes
Not eligible for conventional allogeneic HSCT AND must have disease that is expected to be stable for at least 100 days without chemotherapy
Available HLA-matched related donor
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Under 75
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| 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 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Germany | |
| Medizinische Universitaetsklinik I at the University of Cologne | Recruiting |
| Cologne, Germany, D-50924 | |
| Contact: Kai Huebel, MD 49-221-478-3583 kai.huebel@uni-koeln.de | |
| Universitaet Leipzig | Recruiting |
| Leipzig, Germany, D-04103 | |
| Contact: Dietger Niederwieser, MD 49-341-971-3050 dietger@medizin.uni_leipzig.de | |
| Universitaetsklinikum Tuebingen | Recruiting |
| Tuebingen, Germany, D-72076 | |
| Contact: Wolfgang Bethge, MD 49-4707-1298-2711 | |
| Italy | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Recruiting |
| Turin, Italy, 10126 | |
| Contact: Benedetto Bruno, MD, PhD 39-339-112-9064 benedetto.bruno@unito.it | |
| Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Brenda Sandmaier ) |
| Study ID Numbers: | CDR0000346618, FHCRC-1813.00 |
| Study First Received: | January 9, 2004 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075478 History of Changes |
| Health Authority: | Unspecified |
|
refractory multiple myeloma recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult lymphoblastic lymphoma recurrent adult diffuse large cell lymphoma recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia refractory chronic lymphocytic leukemia relapsing chronic myelogenous leukemia |
previously treated myelodysplastic syndromes recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia recurrent adult Burkitt lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Preleukemia Acute Myelocytic Leukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid |
Multiple Myeloma B-cell Lymphomas Fludarabine Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Antimetabolites Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Immunologic Factors Hematologic Neoplasms Precancerous Conditions Blood Protein Disorders Hodgkin Lymphoma, Childhood Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses |
Syndrome Cardiovascular Diseases Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Vascular Diseases Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Lymphatic Diseases |