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NCT00042354 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients

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

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00042354: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.

NCT00042354 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00042354, 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. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)

Interventions

  • DRUG clofarabine (IV formulation)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2002-05
Est. Completion 2004-08
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00042354 record still lists

NCT00042354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

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

NCT00042354 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00042354 about?

NCT00042354 is a clinical study titled "Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients". 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. The purpose of this study is to determine whether Clofarabine is...

What is the current status of trial NCT00042354?

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 2004-08.

What interventions are being tested in trial NCT00042354?

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

Who is sponsoring clinical trial NCT00042354?

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

How this trial's enrollment target compares

Where NCT00042354's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00042354, the US trial registry maintained by the National Library of Medicine. NCT00042354 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.