Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
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| ClinicalTrials.gov Identifier: NCT00003572 |
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Recruitment Status :
Completed
First Posted : February 20, 2004
Last Update Posted : May 2, 2014
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that have been destroyed by radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation.
PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes | Biological: peripheral blood lymphocyte therapy Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy | Phase 2 |
OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can be achieved in patients treated with total body irradiation before transplant and tacrolimus and mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of this regimen. III. Characterize immune reconstitution of patients during this treatment regimen. IV. Document the incidence of aplasia and graft-versus-host disease associated with donor leukocyte infusions when administered after this regimen.
OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day 0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0. Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor chimerism is less than 80%, there is no active graft-versus-host disease, no disease progression, less than 50% decrease in donor cell chimerism from last measurement, and the patient is not taking immunosuppressive agents, then donor leukocyte infusions are administered on days 70, 194, and 306. Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Primary Purpose: | Treatment |
| Official Title: | Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies |
| Study Start Date : | August 1998 |
| Actual Primary Completion Date : | April 2002 |
| Actual Study Completion Date : | April 2002 |
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Must have a 6 antigen HLA identical related donor and one of the following diseases: -Acute myelogenous leukemia in high risk first complete remission or second or greater complete remission -Acute lymphocytic leukemia in high risk first complete remission or second or greater remission -Chronic myelogenous leukemia in chronic phase -Indolent non-Hodgkin's lymphoma (NHL) or aggressive NHL in complete or partial remission, not eligible for autologous bone marrow transplant (ABMT) -Multiple myeloma in complete or partial response -Myelodysplastic syndrome -Stage III or IV chronic lymphocytic leukemia -Hodgkin's disease after first complete remission Patients must also have one of the following high risk features: -Age 55-70 -Age 18-54 must have one of the following conditions: LVEF 35-44% FEV1 or FVC 40-49% Bilirubin 2.1-3.0 mg/dL, AST 71-175, or ALT 81-200 Creatinine 2.1-3.0 mg/dL Disease recurrence less than 1 year after ABMT Between 18 to 24 months of prior chemotherapy (12 to 24 months for multiple myeloma)
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3.1 mg/dL Renal: Creatinine less than 3.1 mg/dL Cardiovascular: LVEF at least 35% Pulmonary: FEV1 and FVC at least 40% of predicted (60% for patients who have received thoracic or mantle radiotherapy) Other: Not pregnant Fertile patients must use effective contraception Not HIV positive
PRIOR CONCURRENT THERAPY: See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003572
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Ephraim J. Fuchs, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00003572 |
| Other Study ID Numbers: |
CDR0000066639, J9845 R01CA067782 ( U.S. NIH Grant/Contract ) P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-98070603 JHOC-9845 NCI-H98-0023 |
| First Posted: | February 20, 2004 Key Record Dates |
| Last Update Posted: | May 2, 2014 |
| Last Verified: | May 2014 |
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stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma Waldenstrom macroglobulinemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission stage I grade 1 follicular lymphoma |
stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage I adult Burkitt lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Myelodysplastic Syndromes Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Mycophenolic Acid Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Calcineurin Inhibitors |