Total-Body Irradiation and Chemotherapy Followed By Donor Bone Marrow Transplant in Treating Young Patients With Hematologic Cancer
Leukemia, Lymphoma, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood lymphoblastic lymphoma, chronic phase chronic myelogenous leukemia, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, myelodysplastic/myeloproliferative neoplasm, unclassifiable
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following diagnoses: Histologically confirmed good-risk acute myeloid leukemia (AML) in first remission with an HLA-compatible related donor Ineligible for unrelated bone marrow transplantation unless failed first-line induction chemotherapy or have molecular evidence of disease at time of transplantation Histologically confirmed high-risk AML in first remission High risk defined by cytogenetics, biphenotypic and undifferentiated leukemia phenotype, secondary AML, or AML after myelodysplastic syndromes (MDS) Eligible for related or unrelated donor transplantation Histologically confirmed acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) in first remission with high risk for relapse or in second or third remission High risk for relapse defined by hypodiploidy, pseudodiploidy with translocations t(9;22) or infant t(4;11), or failure to achieve remission after four weeks of induction therapy Eligible for related or unrelated donor transplantation Histologically confirmed chronic myelogenous leukemia (CML) in at least first chronic phase or acceleration with an HLA-compatible related donor Histologically confirmed CML in first chronic phase if failed conventional therapy or in at least second chronic phase or acceleration with an HLA-compatible unrelated donor Histologically confirmed non-Hodgkin's lymphoma beyond first complete remission or primary induction failure and tumors that are chemosensitive defined as at least 50% reduction in mass size Eligible for related or unrelated donor transplantation Histologically confirmed MDS with intermediate or high-risk disease defined by International Prognostic Scoring System and paroxysmal nocturnal hematuria Eligible for related or unrelated donor transplantation Treatment-related MDS or leukemia allowed if primary malignancy (e.g., neuroblastoma or Ewing's sarcoma) at low risk of recurrence No AML, ALL, or LL in relapse or greater than third remission No CML in blast crisis defined as more than 30% blasts plus promyelocytes No active CNS involvement History of leukemia cutis allowed HLA compatible donor available 5/6 or 6/6 HLA antigen matched related or unrelated PATIENT CHARACTERISTICS: Age: 18 and under Performance status: Karnofsky 70-100% OR Lansky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST no greater than 3 times ULN (unless liver involvement is present) Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% at rest (if less than 50% at rest, must increase with exercise) Pulmonary: Asymptomatic with no prior risk features OR DLCO greater than 40% predicted (corrected for hemoglobin) if symptomatic Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV I/II negative No uncontrolled viral, bacterial, or fungal infection No known hypersensitivity to bovine proteins PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characterisitics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy that would preclude total body irradiation dose Surgery: Not specified
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Pts < than or = 18 years with lymphohematopoietic disorders
This is a phase II, single-center study to evaluate a cytoreductive regimen of hyperfractionated TBI, thiotepa and cyclophosphamide (HFTBI/thio/cy) followed by infusions of SBA-E- T-cell depleted marrow in pediatric leukemia recipients of either HLA-identical or HLA-1Ag non-identical related or unrelated donors.