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Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Not Recruiting
Trial ID: NCT01297543
Purpose
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
Stanford Investigator(s)
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
Key Inclusion Criteria:
- 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:
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
Intervention(s):
biological: human myeloid progenitor cells
drug: G-CSF
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061