Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

This is an interventional treatment trial for Leukemia focused on measuring chronic myelogenous leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, atypical chronic myeloid leukemia, chronic myelomonocytic leukemia, anaplastic large cell lymphoma, splenic marginal zone lymphoma, nodal marginal zone B-cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent childhood large cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, recurrent/refractory childhood Hodgkin lymphoma, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, refractory multiple myeloma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, childhood myelodysplastic syndromes, recurrent childhood anaplastic large cell lymphoma, refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage III childhood anaplastic large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood anaplastic large cell lymphoma, stage IV childhood large cell lymphoma, stage III adult Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, stage II multiple myeloma, stage III multiple myeloma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, Waldenstrom macroglobulinemia, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, juvenile myelomonocytic leukemia, chronic eosinophilic leukemia, chronic idiopathic myelofibrosis, chronic neutrophilic leukemia, essential thrombocythemia, polycythemia vera Read More

DISEASE CHARACTERISTICS:

• Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following:

  • Acute myeloid leukemia in complete remission (CR)* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:

    • In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following:

      • Preceding myelodysplastic syndromes (MDS)
      • High-risk cytogenetics (e.g., monosomy 5 or 7, or as defined by referring institution treatment protocol)
      • Required > 2 courses of therapy to obtain CR
      • Erythroblastic or megakaryocytic leukemia
    • In second CR (CR2) or beyond

  • Acute lymphoblastic leukemia in CR* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:

    • In CR1 AND has high-risk disease as evidenced by any of the following:

      • t(9;22), t(1;19), t(4;11), or other MLL rearrangements
      • Hyplodiploid
      • Required > 1 course of therapy to obtain CR
    • Beyond CR2

  • Chronic myelogenous leukemia (CML)

    • All types are allowed (except refractory blast crisis CML)
    • Patients in chronic phase CML must have failed or been intolerant to prior imatinib mesylate (Gleevec) or other tyrosine kinase inhibitors

  • MDS

    • Any subtype allowed (including refractory anemia [RA])
    • Severe pancytopenia or complex cytogenetics
    • Blasts must be < 5% (if blasts are ≥ 5%, pre-transplant induction therapy is required to reduce blast count to < 5%)

  • Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma, meeting one of the following criteria:

    • Chemotherapy-sensitive disease that has failed prior therapy

      • Patients with large cell lymphoma or Hodgkin lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)
    • Ineligible for an autologous stem cell transplant

  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after ≥ 2 prior therapies

    • Patients with bulky disease should be considered for debulking chemotherapy prior to transplant
    • Patients with refractory disease are eligible provided disease is non-bulky AND an estimated tumor doubling time is ≥ 1 month

  • Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia

    • Chemotherapy-sensitive disease that was previously treated with initial therapy

      • Patients with mantle cell lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)
  • Mycosis fungoides and Sezary syndrome
  • Bone marrow failure syndromes, except for Fanconi anemia
  • Myeloproliferative syndromes NOTE: *Patients for whom adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment must have fulfilled criteria of remission (< 5% blasts by flow cytometry and recovery of peripheral blood counts with no circulating blasts)

• Ineligible for autologous stem cell transplant due to any of the following:

  • Prior autologous stem cell transplant
  • Inadequate autologous stem cell harvest
  • Inability to withstand a myeloablative preparative regimen
  • Clinically aggressive/high-risk disease
• No evidence of progressive disease by imaging modalities or biopsy (persistent PET scan activity allowed provided there are no CT scan changes indicating progression)
• Acute leukemia that is refractory, persistent, or relapsed (defined as > 5% blasts in normocellular bone marrow) allowed provided patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy
• Patients with stable disease are eligible provided the largest residual nodal mass is approximately < 5 cm (largest residual mass must represent a 50% reduction and be approximately < 7.5 cm for patients who have responded to prior therapy)
• No active CNS malignancy

• Umbilical cord blood (UCB) donor available

  • UCB graft matched at 4/6 HLA-A, -B, and -DRB1 antigens with the recipient

    • May include 0-2 antigen mismatches at the A, B, or DRB1 loci
    • Unit selection based on cryopreserved nucleated cell dose and HLA-A, -B, and -DRB1 using intermediate resolution A, B antigen and DRB1 allele typing
  • If 2 UCB units are required to reach the target cell dose, each unit must be a 3/6 HLA-A, -B, and -DRB1 antigen match to each other, as well as a 4/6 antigen match to the recipient
  • No 5-6/6 HLA-A, -B, and -DRB1 matched sibling donor available

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100%

• Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatrics)

  • Adult patients with a creatinine > 1.2 mg/dL or a history of renal dysfunction must have an estimated creatinine clearance of > 40 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• LVEF ≥ 35%
• DLCO > 30% predicted
• No requirement for O_2
• No decompensated congestive heart failure
• No uncontrolled arrhythmia

• None of the following liver diseases or conditions:

  • Fulminant liver failure
  • Cirrhosis with evidence of portal hypertension or bridging fibrosis
  • Alcoholic hepatitis
  • Esophageal varices
  • History of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time
  • Ascites related to portal hypertension
  • Bacterial or fungal abscess
  • Biliary obstruction
  • Chronic viral hepatitis with total serum bilirubin > 3 mg/dL
  • Symptomatic biliary disease
• Recent mold infection (e.g., Aspergillus) allowed provided patient received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by Infectious Disease
• No evidence of HIV infection or known HIV-positive serology
• No uncontrolled viral or bacterial infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 months since prior myeloablative stem cell transplantation