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NCT00044889 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

A Phase 2 study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00044889 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants.

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The verdict

NCT00044889, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.

Interventions

  • DRUG clofarabine (IV formulation)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2002-05
Est. Completion 2003-03
Phase Phase 2

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT00044889

The ClinicalTrials.gov registry entry for NCT00044889 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which clofarabine (IV formulation) is the first listed.

NCT00044889 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00044889 about?

NCT00044889 is a clinical study titled "Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia". Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a single arm, open-label, Phase II study of CLOFARABINE ...

What is the current status of trial NCT00044889?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2002-05. Estimated completion is 2003-03.

What interventions are being tested in trial NCT00044889?

The interventions under investigation include: clofarabine (IV formulation) (DRUG).

Who is sponsoring clinical trial NCT00044889?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

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.