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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 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.

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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

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Myelodysplasia

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

3 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, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower). The listed sponsor is Cellerant Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.