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NCT01655875 · ClinicalTrials.gov registry record · Phase 1

AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia

A Phase 1 study, sponsored by Emory University.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT01655875 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 1 participants.

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The verdict

NCT01655875, a Phase 1 study, was terminated before completion, sponsored by Emory University.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

This study is for patients 2-21 years old who have acute leukemia that has not responded well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide). The conditioning regimen is the treatment that is given just before the transplant. This treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow samples from study participants will be collected to find out if AMD3100 is making patients' cells more sensitive to the conditioning regimen and to find out how it does this. The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that three doses do not significantly increase the side effects of transplant conditioning, the investigators will give a second group of six patients five daily doses.

Interventions

  • DRUG AMD3100

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2012-06
Est. Completion 2014-04
Phase Phase 1

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT01655875

The ClinicalTrials.gov registry entry for NCT01655875 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AMD3100 is the first listed.

NCT01655875 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01655875 about?

NCT01655875 is a clinical study titled "AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia". This study is for patients 2-21 years old who have acute leukemia that has not responded well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard pre-transplant conditioni...

What is the current status of trial NCT01655875?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-06. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01655875?

The interventions under investigation include: AMD3100 (DRUG).

Who is sponsoring clinical trial NCT01655875?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.