RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell 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 stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.
OBJECTIVES: * Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies. * Determine the toxicity of this regimen in these patients. * Determine the relapse rate and survival rate in patients treated with this regimen. * Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen. OUTLINE: Patients receive 1 of the following preparative regimens: * Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1. * Regimen B-1: Patients receive cyclophosphamide IV and TBI as in regimen A. * Regimen B-2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1. * Regimen B-3: Patients receive TBI on days -7 to -5. Patients receive cyclophosphamide IV over on days -4 to -3. * Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2. * Regimen D: Patients receive TBI on days -6 to -4. Patients receive etoposide infusion on day -3. All patients undergo stem cell transplantation from a matched, unrelated donor on day 0. Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: 50
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Given orally 1mg/kg/dose (or 40mg/m2/dose for young children)
Given IV
Given IV
Patients undergo total body irradiation
infusion
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Rates of Durable Engraftment
Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.
Time frame: at day 42
Graft-versus-host Disease (GVHD)
Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.
Time frame: at 100 days post transplant
Incidence of Recurrent Disease
Number of patients that have disease recurrence.
Time frame: at day 100 post transplant
Toxicity as Measured by CTC v2.0
Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.
Time frame: at 100 days post transplant
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