Trials / Completed
CompletedNCT01297543
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Cellerant Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | human myeloid progenitor cells | Single intravenous injection/infusion |
| DRUG | G-CSF | Background therapy |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2014-11-01
- Completion
- 2015-01-01
- First posted
- 2011-02-16
- Last updated
- 2016-07-01
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01297543. Inclusion in this directory is not an endorsement.