Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

Key Inclusion Criteria:

• Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:

  • High risk acute myeloid leukemia (AML) in complete remission
  • Very high risk pediatric AML; patients <21 years eligible with <25% blasts in marrow after failed chemotherapy
  • High risk acute lymphocytic leukemia (ALL) in complete remission
  • Chronic myelogenous leukemia (CML), excluding refractory blast crisis
  • Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
  • Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
  • Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
  • Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission (chemotherapy refractory large cell NHL not eligible)
  • Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in complete or partial remission, or after progression if stage I/II <1 year (chemotherapy refractory high-grade NHL not eligible)
  • Multiple myeloma beyond 2nd partial remission
• Preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
• Adequate organ function

Key Exclusion Criteria:

• Symptomatic underlying pulmonary disease or requiring oxygen
• Active infection
• HIV positive
• Pregnant or nursing