Last Verified: | May/31/2016 |
First Submitted: | January/26/2003 |
Estimated Enrollment Submitted: | January/26/2003 |
First Posted: | January/27/2003 |
Last Update Submitted: | June/29/2016 |
Last Update Posted: | June/30/2016 |
Actual Study Start Date: | November/30/2002 |
Estimated Primary Completion Date: | October/31/2006 |
Estimated Study Completion Date: | July/31/2010 |
Study Type: | Interventional |
Allocation: | Non-Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Non myeloblative allogeneic transplant Non myeloblative allogeneic hematopoietic cell transplantation after prior autologous transplantation | Biological: Non myeloblative allogeneic transplant 2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | DISEASE CHARACTERISTICS: - Histologically confirmed hematologic malignancy, including one of the following: - Chronic lymphocytic leukemia (CLL) - Absolute lymphocytosis greater than 5,000/mm^3 - Lymphocytes must appear morphologically mature with less than 55% prolymphocytes - Lymphocyte phenotype with expression of CD19 and CD5 - Prolymphocytic leukemia (PLL) - Morphologically confirmed - Absolute lymphocytosis greater than 5,000/mm^3 - More than 55% prolymphocytes - Non-Hodgkin's lymphoma or Hodgkin's lymphoma - Any WHO histologic subtype allowed except mantle cell lymphoma - Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping - No bone marrow biopsy as the sole diagnostic means for follicular lymphoma - Multiple myeloma - Active disease requiring treatment - Durie-Salmon stage I, II, or III - Acute myeloid leukemia - Documented control (i.e., less than 10% bone marrow blasts and no circulating blasts) - Myelodysplastic syndromes - Documented disease by WHO criteria - Must have evidence of relapse/progression at least 6 months after prior high-dose chemotherapy with autologous hematopoietic stem cell support - Absence of CD23 expression for CLL or PLL allowed provided there is no morphologic evidence of mantle cell lymphoma - Availability of any of the following donor types: - HLA-identical sibling (6/6) - 9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci - Only a single mismatch at one class I or II allele allowed - 10/10 matched unrelated donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci - No syngeneic donors PATIENT CHARACTERISTICS: Age - Under 70 Performance status - Not specified Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 3 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal - Creatinine clearance at least 40 mL/min Cardiovascular - LVEF at least 30% by MUGA Pulmonary - DLCO greater than 40% - No symptomatic pulmonary disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No uncontrolled diabetes mellitus - No active serious infection - No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - More than 4 weeks since prior surgery |