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NCT00702403 · ClinicalTrials.gov registry record · Phase 1

Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT00702403: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT00702403 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00702403, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This phase I/II trial is studying the side effects and best way to give nilotinib when given alone or sequentially after imatinib mesylate after donor stem cell transplant in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after t

Interventions

  • DRUG imatinib mesylate
  • OTHER pharmacological study
  • DRUG nilotinib

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2008-08-14
Est. Completion 2013-12-01
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00702403 record still lists

NCT00702403 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

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

NCT00702403 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00702403 about?

NCT00702403 is a clinical study titled "Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML". This phase I/II trial is studying the side effects and best way to give nilotinib when given alone or sequentially after imatinib mesylate after donor stem cell transplant in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and imatinib mesylate may stop...

What is the current status of trial NCT00702403?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-08-14. Estimated completion is 2013-12-01.

What interventions are being tested in trial NCT00702403?

The interventions under investigation include: imatinib mesylate (DRUG), pharmacological study (OTHER), nilotinib (DRUG).

Who is sponsoring clinical trial NCT00702403?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00702403's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00702403, the US trial registry maintained by the National Library of Medicine. NCT00702403 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.