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COMPLETED Phase 1

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

NCT01297543 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 45 participants
Start Date 2011-03
Est. Completion 2015-01
Phase Phase 1

Sponsor

Cellerant Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01297543

The ClinicalTrials.gov registry entry for NCT01297543 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cellerant Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01297543 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01297543?

The interventions under investigation include: G-CSF (DRUG), human myeloid progenitor cells (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01297543?

This trial is sponsored by Cellerant Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial