Trial | NCT00891137  Report issue

Title

Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy
A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
Study Started
Apr 30
2009
Primary Completion
Jun 30
2014
Study Completion
Jun 30
2014
Last Update
Oct 27
2014
Estimate

Biological human myeloid progenitor cells

Single intravenous injection/infusion

  • Other names: CLT-008, hMPC

Group A Experimental

Low dose, single donor CLT-008 (human myeloid progenitor cells)

Group B Experimental

Low dose, multiple donor CLT-008 (human myeloid progenitor cells)

Group C Experimental

Intermediate dose, multiple donor CLT-008 (human myeloid progenitor cells)

Group D Experimental

High dose, multiple donor CLT-008 (human myeloid progenitor cells)

Criteria 

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
No Results Posted