| Last Verified: | July/31/2018 |
| First Submitted: | March/26/2007 |
| Estimated Enrollment Submitted: | March/26/2007 |
| First Posted: | March/27/2007 |
| Last Update Submitted: | August/6/2018 |
| Last Update Posted: | September/9/2018 |
| : | May/27/2014 |
| : | June/29/2014 |
| : | July/1/2014 |
| Actual Study Start Date: | January/31/2007 |
| Estimated Primary Completion Date: | January/31/2014 |
| Estimated Study Completion Date: | July/31/2014 |
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
| Study Type: | Interventional |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Inclusion Criteria: - Histologically confirmed hematological disease, including any of the following: - Chronic lymphocytic leukemia - Absolute lymphocytosis > 5,000/µL - Morphologically mature lymphocytes with < 55% prolymphocytes - Lymphocyte phenotype with expression of CD19 and CD5 - Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma - Prolymphocytic leukemia - Absolute lymphocytosis > 5,000/µL - Morphologically mature lymphocytes with > 55% prolymphocytes - Non-Hodgkin's or Hodgkin's lymphoma - Any WHO classification histologic subtype - Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping - Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas - Multiple myeloma - Has received ≥ 1 prior treatment regimen - Has a partial response or greater by the Blade Criteria - Patients who achieved complete remission are eligible - Acute myeloid leukemia - Documented control (i.e., < 10% bone marrow blasts and no circulating blasts) - Myelodysplastic syndromes - Documented disease as defined by WHO or French-American-British Cooperative group criteria - Chronic myelogenous leukemia - Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible - Polycythemia vera - Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B): - A1: Total red blood cell mass > 25% above mean normal predicted value OR hemoglobin > 18.5 g/dL in males, 16.5 g/dL in females (hematocrit ≥ 60% in males or ≥ 56% in females) - A2: No cause of secondary erythrocytosis (absence of familial erythrocytosis, no elevation of epoetin alfa [EPO] due to hypoxia, high oxygen affinity hemoglobin, truncated EPO receptor, or inappropriate ectopic EPO production) - A3: Splenomegaly - A4: Clonal genetic abnormality other than the Philadelphia chromosome - A5: Endogenous erythroid colony formation in vitro - B: Platelet count > 400,000/mm³, WBC > 12,000/mm³, bone marrow biopsy with prominent erythroid and megakaryocytic proliferation, and low serum EPO - Chronic idiopathic myelofibrosis - Documented disease as defined by WHO criteria - Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria: - HLA-identical sibling (6/6) - Serologic typing for class I (A, B) - Molecular typing for class II (DRB1) - 9/10 matched related donor - High-resolution molecular typing at HLA-A, B, C, DRB1, and DQB1 - Only a single mismatch at one class I or II allele allowed - 10/10 matched unrelated donor - Molecular identity at HLA-A, B, C, DRB1, and DQB1 by high-resolution typing - Syngeneic donors are not eligible - Creatinine clearance ≥ 40 mL/min - Bilirubin ≤ 3 times upper limit of normal (ULN) - AST ≤ 3 times ULN - DLCO ≥ 40% with no symptomatic pulmonary disease - LVEF ≥ 30% by cardiac MRI or echocardiogram with no symptomatic cardiac disease - Fertile patients willing to use effective contraception Exclusion Criteria: - Uncontrolled diabetes mellitus - Active serious infection - Known hypersensitivity to E. coli-derived products - Known HIV positivity - History of another malignancy*, meeting the following criteria: - Non-skin malignancy or melanoma within the past 5 years - Concomitant malignancy that has not been curatively treated - NOTE: *However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of < 30% for recurrence by their treating physicians is considered - Pregnant or nursing |