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NCT00381680 · ClinicalTrials.gov registry record · Phase 3

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

A Phase 3 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
275
Enrollment target

NCT00381680: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00381680 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 275 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00381680, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
275 participants
Enrollment target

Study Summary

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..

Primary Outcome

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).

Interventions

  • DRUG prednisone
  • DRUG doxorubicin hydrochloride
  • DRUG cytarabine
  • DRUG vincristine sulfate
  • DRUG pegaspargase

Trial Details

FieldValue
Enrollment Target 275 participants
Start Date 2007-03
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00381680 record still lists

NCT00381680 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).

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

NCT00381680 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00381680 about?

NCT00381680 is a clinical study titled "Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia". This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs use...

What is the current status of trial NCT00381680?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2007-03.

What interventions are being tested in trial NCT00381680?

The interventions under investigation include: prednisone (DRUG), doxorubicin hydrochloride (DRUG), cytarabine (DRUG), vincristine sulfate (DRUG), pegaspargase (DRUG).

Who is sponsoring clinical trial NCT00381680?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00381680's enrollment target sits among peer trials

275 1206th of 2000 higher than 794 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00381680, the US trial registry maintained by the National Library of Medicine. NCT00381680 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.