Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Eligibility Criteria
Inclusion Criteria: Patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or multiple myeloma who are not eligible for a curative autologous transplantation or who have received a prior autologous transplantation; patients with NHL or CLL must have failed prior therapy with an alkylating agent and/or fludarabine, or be at high risk of relapse; patients with multiple myeloma must have stage II or III disease and received prior chemotherapy Patients < 50 years of age with NHL, Hodgkin's disease (HD), CLL or multiple myeloma at high risk of regimen related toxicity through prior autologous transplant or through pre-existing medical conditions Patients < 75 years of age with other malignant diseases treatable by allogeneic bone marrow transplant (BMT) whom through pre-existing chronic disease affecting kidneys, liver, lungs, and heart are considered to be at high risk for regimen related toxicity using standard high dose regimens; the following diseases are the likely candidates Myelodysplastic syndromes Myeloproliferative syndromes Acute Leukemia with < 10% blasts Amyloidosis Hodgkin's disease The Fred Hutchinson Cancer Research Center (FHCRC) Patient Care Conference (PCC) may approve patients with other malignancies or patients declining standard allografts for transplant following presentation and approval; centers outside the FHCRC that have a PCC or equivalent should obtain their Institutional approval; if there is not a comparable group at the Institution, please contact the FHCRC Principal Investigator for FHCRC approval through PCC DONOR: Human leukocyte antigen (HLA) genotypically or phenotypically identical related donor DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) Exclusion Criteria: Eligible for a high-priority curative autologous transplant Patients with rapidly progressive aggressive NHL unless in minimal disease state Any current central nervous system (CNS) involvement with disease Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Females who are pregnant Patients who are human immunodeficiency virus (HIV) positive Cardiac ejection fraction < 40%; ejection fraction is required if the patient has a history of anthracyclines or history of cardiac disease Receiving supplementary continuous oxygen Diffusing capacity of the lung for carbon monoxide (DLCO) < 30% Total lung capacity (TLC) < 30% Forced expiratory volume in one second (FEV1) < 30% Total bilirubin > 2x the upper limit of normal Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) 4x the upper limit of normal Karnofsky score < 50 Patients with poorly controlled hypertension who are unable to have blood pressure kept below 150/90 on standard medication Patients with renal failure are eligible, however patients with renal compromise (serum creatinine greater than 2.0) will likely have further compromise in renal function and may require hemodialysis (which may be permanent) due to the need to maintain adequate serum cyclosporine levels The addition of cytotoxic agents for "cytoreduction" with the exception of hydroxyurea and imatinib mesylate will not be allowed within two weeks of the initiation of conditioning DONOR: Identical twin DONOR: Age less than 12 years DONOR: Pregnancy DONOR: Infection with HIV DONOR: Inability to achieve adequate venous access DONOR: Known allergy to G-CSF DONOR: Current serious systemic illness
Sites / Locations
- University of Arizona Health Sciences Center
- City of Hope Medical Center
- Stanford University Hospitals and Clinics
- OHSU Knight Cancer Institute
- Baylor University Medical Center
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Froedtert Hospital
- Universitaet Leipzig
- University of Torino
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (indolent disease)
Arm II (aggressive disease)
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV every 8-12 hours on days 0 to 27.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate and undergo TBI as in Arm I. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 70 and mycophenolate mofetil as in Arm I.