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NCT00039377 · ClinicalTrials.gov registry record · Phase 2

Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT00039377: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00039377 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00039377, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study Summary

This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia.

Primary Outcome

Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method. A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils \>= 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemi

Interventions

  • DRUG imatinib mesylate
  • DRUG leucovorin calcium
  • DRUG methotrexate
  • PROCEDURE peripheral blood stem cell transplantation
  • DRUG vincristine sulfate

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2002-04
Est. Completion 2014-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00039377 record still lists

NCT00039377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 5 interventions - of which imatinib mesylate is the first listed.

NCT00039377 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00039377 about?

NCT00039377 is a clinical study titled "Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia". This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they sto...

What is the current status of trial NCT00039377?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2002-04. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00039377?

The interventions under investigation include: imatinib mesylate (DRUG), leucovorin calcium (DRUG), methotrexate (DRUG), peripheral blood stem cell transplantation (PROCEDURE), vincristine sulfate (DRUG).

Who is sponsoring clinical trial NCT00039377?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00039377's enrollment target sits among peer trials

58 1135th of 2000 higher than 860 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 NCT00039377, the US trial registry maintained by the National Library of Medicine. NCT00039377 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.