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NCT01297543 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Cellerant Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 10
- Study locations
NCT01297543: Completed Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Cellerant Therapeutics.
NCT01297543 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that has completed, run by Cellerant Therapeutics. The registered enrollment target is 45 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297543, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, has completed, sponsored by Cellerant Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- DRUG G-CSF
- BIOLOGICAL human myeloid progenitor cells
Study Locations (10)
California
- Moores UCSD Cancer Center - La Jolla
- University of California San Francisco Medical Center - San Francisco
- Stanford Hospital and Clinics - Stanford
Illinois
- Loyola University Medical Center, Cardinal Bernardin Cancer Center - Maywood
Indiana
- Indiana Blood and Marrow Transplantation, LLC - Beech Grove
Massachusetts
- University of Massachusetts Memorial Medical Center - Worcester
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- The Western Pennsylvania Hospital - Pittsburgh
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01297543 record still lists
NCT01297543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which G-CSF is the first listed.
NCT01297543 lists 10 locations in 8 states (California, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT01297543 about?
NCT01297543 is a clinical study titled "Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia". 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 le...
What is the current status of trial NCT01297543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2011-03. Estimated completion is 2015-01.
What conditions does trial NCT01297543 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia.
What interventions are being tested in trial NCT01297543?
The interventions under investigation include: G-CSF (DRUG), human myeloid progenitor cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01297543?
This trial is sponsored by Cellerant Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01297543 being conducted?
This trial has 10 study locations across California, Illinois, Indiana, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01297543's enrollment target sits among peer trials
45 158th of 306 higher than 145 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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