Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Hematological malignancy, including: - AML, ALL or MDS - Planned treatment with cytarabine-based chemotherapy regimen - Adequate hepatic, renal, hematologic, cardiac and respiratory function Key
Exclusion Criteria:
  1. - Prior allograft or history of active GVHD within 3 years - Pregnant or nursing


Jason Gotlib
Professor of Medicine (Hematology)

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Cancer Clinical Trials Office