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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00134004 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to risk of relapse (standard [defined as ≤ 30% risk] vs high [defined as ≥ 70% risk]).
After completion of study transplantation, patients are followed on days 30, 60, 100, and 180; at 1 year; and then annually for 4 additional years.
PROJECTED ACCRUAL: A total of 75-100 patients will be accrued for this study within 3-4 years.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute leukemia
In first CR with any of the following poor-risk cytogenetic features:
Chronic phase chronic myelogenous leukemia (CML)
Chronic lymphocytic leukemia, meeting 1 of the following criteria:
Received 1 prior therapy and has any of the following high-risk features:
Hodgkin's lymphoma
Ineligible for autologous stem cell transplantation (SCT) due to any of the following exclusion factors:
Non-Hodgkin's lymphoma (NHL)
Chronic myeloproliferative disorders other than CML, including any of the following:
Polycythemia vera or essential thrombocythemia in "spent" phase, with a history of 2 of the following:
Must have an HLA mismatched (i.e., 3/6, 4/6, or 5/6) related (first-degree relative)* donor available
NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
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, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| Study Chair: | Ephraim J. Fuchs, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Ephraim J. Fuchs ) |
| Study ID Numbers: | CDR0000440990, JHOC-J0457, JHOC-04072704 |
| Study First Received: | August 22, 2005 |
| Last Updated: | February 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00134004 History of Changes |
| Health Authority: | Unspecified |
|
adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia refractory chronic lymphocytic leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) chronic idiopathic myelofibrosis chronic myelomonocytic leukemia |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes 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 Burkitt lymphoma |
|
Polycythemia Chronic Myelomonocytic Leukemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Tacrolimus Follicular Lymphoma Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Thrombocythemia, Hemorrhagic Hodgkin Disease |
Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma B-cell Lymphomas Fludarabine Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Antimetabolites Acute Lymphoblastic Leukemia, Childhood |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Tacrolimus Cyclophosphamide Hemostatic Disorders Leukemia Preleukemia Pathologic Processes |
Hemorrhagic Disorders Therapeutic Uses Syndrome Lymphoma, Large-Cell, Immunoblastic Mycophenolate mofetil Cardiovascular Diseases Alkylating Agents Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders |