drugset / Trial / NCT01297543
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Phase 1/2
Completed
45 enrolled
Cellerant Therapeutics
Department of Health and Human Services · collab
Non-randomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2011-03
- Primary completion
- 2014-11
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human myeloid progenitor cells | Cell therapy | — | Intravenous |
| Background | G-CSF | Unknown | — | — |