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Brief Title: Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Official Title: A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
Study ID: NCT01297543
Brief Summary: Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moores UCSD Cancer Center, La Jolla, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center, Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation, LLC, Beech Grove, Indiana, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States