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Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
This study is ongoing, but not recruiting participants.
Study NCT00003572   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
August 1998
 
 
 
Complete list of historical versions of study NCT00003572 on ClinicalTrials.gov Archive Site
 
 
 
Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies

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.

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.

Phase II
Interventional
Treatment
  • 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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
 
 

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003572
 
CDR0000066639, JHOC-98070603, JHOC-9845, NCI-H98-0023
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Ephraim J. Fuchs, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP