Non Hodgkin Lymphoma Clinical Trial
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Full Description
OBJECTIVES:
Primary
Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies.
Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen.
Determine other toxic effects of this regimen in these patients.
Secondary
Determine immune reconstitution in patients treated with this regimen.
Determine disease control in patients treated with this regimen.
OUTLINE: This is a pilot study. Patients are stratified according to age (≤ 19 years old vs > 19 years old).
Myeloablative conditioning chemotherapy: Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1.
Allogeneic bone marrow transplantation: Patients undergo allogeneic bone marrow transplantation on day 0.
Immunosuppression therapy: Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4.
After completion of study transplantation, patients are followed at 30 and 60 days, 6 months, 1 year, and then annually thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
AML beyond first complete remission (CR1)
Refractory AML
AML arising from myelodysplastic syndromes (MDS)
Secondary AML
MDS
Refractory anemia with excess blasts with > 10% blasts in bone marrow
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
ALL in CR1 with 1 of the following high-risk features:
Philadelphia chromosome (Ph)-positive disease
Less than 1 year of age at diagnosis
Cytogenetic abnormalities involving chromosome 11q23
ALL beyond CR1
Refractory ALL
Chronic myeloid leukemia beyond first chronic phase
Chronic myelomonocytic leukemia
Chronic lymphocytic leukemia
Stage III-IV disease
Does not meet criteria for other bone marrow transplantation (BMT) studies
Myeloproliferative disorders
Ph-negative disease
Hodgkin's or non-Hodgkin's lymphoma
Chemotherapy-resistant disease
Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
Multiple myeloma
Stage II or III disease
Very high-risk disease
Having an unrelated donor is considered a high-risk condition
Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
Bone marrow donor available, meeting 1 of the following criteria:
Genotypically HLA-identical sibling
Phenotypically matched first-degree relative
Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1
PATIENT CHARACTERISTICS:
Age
6 months to 65 years
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
See Disease Characteristics
Hepatic
Not specified
Renal
Not specified
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
See Disease Characteristics
Endocrine therapy
No concurrent dexamethasone as an antiemetic during immunosuppression therapy
Radiotherapy
Not specified
Surgery
Not specified
Other
No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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