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RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are grouped according to the following strata:
Stratum I: Malignant disease, 5/6 or 6/6 HLA match, age 18 and under
Stratum II: Malignant disease, 4/6 HLA match, age 18 and under
Stratum III: Malignant disease, 3/6 HLA match, age 18 and under
Stratum IV: Malignant disease, 2/6 or 1/6 HLA match, age 18 and under
Stratum V (closed to accrual): Severe aplastic anemia, Fanconi anemia, or other marrow failure syndrome
Stratum VI: Inborn errors of metabolism/storage diseases and other nonmalignant diseases not included in stratum V
Stratum VII: Malignant disease receiving alternative conditioning regimen comprising busulfan and melphalan
Stratum VIII (closed to accrual): Adult patients (over age 18)
Conditioning therapy: Patients are assigned to 1 of 5 groups according to diagnosis.
Allogeneic umbilical cord blood transplantation: All patients undergo umbilical cord blood transplantation on day 0. Beginning on day 0 or 1, patients receive filgrastim (G-CSF) IV or subcutaneously daily until blood counts recover.
Graft-versus-host disease prophylaxis: Patients receive cyclosporine (IV or oral) beginning between days -3 and -1 and continuing for 1 year after transplantation and methylprednisolone twice daily beginning on day 1 and continuing until blood counts recover.
Patients are followed weekly for 14 weeks, at 100 days, and at 4, 5, 6, 9, 12, 18, 24, and 36 months.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML)*
With or without history of myelodysplastic syndromes (MDS)
Patients in first complete remission (CR) (no greater than 5% blasts in marrow) with translocations t(8;21) and inv(16) are allowed provided they failed first-line induction therapy
Patients in first CR (no greater than 5% blasts in marrow) with translocations t(15;17) are allowed provided at least 1 of the following is true:
No patients in first CR and with Down syndrome
Acute lymphoblastic leukemia (ALL)*, meeting 1 of the following criteria:
Not in first CR (no greater than 5% blasts in marrow)
In first CR and high risk as defined by 1 of the following:
Hypoploidy (no more than 44 chromosomes)
Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14) (excluding B-ALL) or +MLL gene rearrangement
One of the following elevated WBC levels:
Failed to achieve CR after 4 weeks of induction therapy
B-ALL that is not in first CR or that meets at least 1 of the high-risk criteria specified above
Undifferentiated leukemia*
Infant leukemia*
Biphenotypic leukemia*
Chronic myelogenous leukemia, meeting 1 of the following criteria:
Accelerated phase
Chronic phase
Blast crisis* (greater than 30% promyelocytes plus blasts in the marrow)
One of the following MDS:
Paroxysmal nocturnal hemoglobinuria
Hodgkin's or non-Hodgkin's lymphoma beyond first CR or failed primary induction therapy
OR
Diagnosis of one of the following nonmalignant diseases :
Acquired severe aplastic anemia (stratum closed to accrual)
Inborn errors of metabolism, including, but not limited to the following:
Fanconi anemia documented by increased chromosomal fragility assays and meeting 1 of the following criteria (stratum closed to accrual):
Severe pancytopenia
Morphologic evidence of MDS with clonal chromosomal abnormalities
Leukemia transformation
Other marrow failure syndromes, including any of the following (stratum closed to accrual):
Combined immune deficiencies including, but not limited to the following:
No active CNS leukemia (cerebrospinal fluid with WBC greater than 5/mm^3 and malignant cells on cytospin)
No SCID patients who do not require cytoreduction
No dyskeratosis congenita
No primary myelofibrosis
No grade 3 or greater myelofibrosis
Familial erythrophagocytic lymphohistiocytosis patients must not have any of the following:
No available 5/6 or 6/6 HLA-matched related donor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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