Non Hodgkin Lymphoma Clinical Trial
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
Full Description
OBJECTIVES:
Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies.
Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients.
Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen.
OUTLINE: This is a dose-escalation study of cyclophosphamide.
Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined.
Patients are followed at 2 and 6 months, at one year, and then annually thereafter.
PROJECTED ACCRUAL: At least 23 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Patients with any of the following diagnoses:
Chronic myelogenous leukemia
Chronic phase 1
Failed prior interferon alfa therapy OR
Relapsed after prior autologous stem cell transplantation
Chronic phase 2
Acute leukemia
Standard risk
Age over 60 years
Complete remission 1 (CR1)
High risk
High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy
CR1
Complete remission 2 or higher
Acute lymphocytic leukemia
CR1 or higher
Myelodysplastic syndrome
Untreated OR
CR1
Acute myeloid leukemia in CR1
Chronic lymphocytic leukemia
Rai stage III or IV OR
Received prior autologous stem cell transplantation
Multiple myeloma
Stage II or III
Stable or progressive disease after prior chemotherapy OR
Received prior autologous stem cell transplantation
Non-Hodgkin's Lymphoma
Hodgkin's lymphoma
Ineligible for or refused autologous or standard allogeneic bone marrow transplantation
Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor
Must have an HLA mismatched, related donor (3-5 out of 6)
PATIENT CHARACTERISTICS:
Age:
0.5 to 70
Performance status:
ECOG 0-1
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin less than 3.1 mg/dL
Renal:
Not specified
Cardiovascular:
Left ventricular ejection fraction at least 35%
Pulmonary:
FEV_1 and FVC at least 40% of predicted OR
FEV_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy
Other:
HIV negative
No other debilitating medical or psychiatric illness that would preclude study compliance
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
No prior transfusions from donor
Chemotherapy:
See Disease Characteristics
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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