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NCT00333840 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,106
Enrollment target

NCT00333840 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,106 participants.

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The verdict

NCT00333840, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,106 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Interventions

  • DRUG imatinib mesilate
  • DRUG interferon-alpha (INF-a)
  • DRUG cytarabine (ARA-C)

Trial Details

FieldValue
Enrollment Target 1,106 participants
Start Date 2000-06
Est. Completion 2012-03
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00333840

The ClinicalTrials.gov registry entry for NCT00333840 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which imatinib mesilate is the first listed.

NCT00333840 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00333840 about?

NCT00333840 is a clinical study titled "Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia". The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus...

What is the current status of trial NCT00333840?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,106 participants. The study started on 2000-06. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00333840?

The interventions under investigation include: imatinib mesilate (DRUG), interferon-alpha (INF-a) (DRUG), cytarabine (ARA-C) (DRUG).

Who is sponsoring clinical trial NCT00333840?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 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.