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NCT00005603 · ClinicalTrials.gov registry record · Phase 3

Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

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

Completed
Registry status
Phase 3
Development phase
276
Enrollment target

NCT00005603: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00005603 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 276 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

NCT00005603, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
276 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leukemia. PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.

Primary Outcome

To determine for patients at high risk for treatment failure if the augmented Berlin Frankfurt Muenster (BFM) therapy is superior to ALinC 14/15 therapy, on the basis of historical controls.

Interventions

  • DRUG cyclophosphamide
  • DRUG dexamethasone
  • DRUG cytarabine
  • DRUG asparaginase
  • DRUG daunorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2000-03
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00005603 record still lists

NCT00005603 is an interventional study that assigns participants to a tested intervention. The registered 276 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 cyclophosphamide is the first listed.

NCT00005603 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005603 about?

NCT00005603 is a clinical study titled "Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leuk...

What is the current status of trial NCT00005603?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2000-03.

What interventions are being tested in trial NCT00005603?

The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), cytarabine (DRUG), asparaginase (DRUG), daunorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00005603?

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 NCT00005603's enrollment target sits among peer trials

276 1202nd of 2000 higher than 795 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 NCT00005603, the US trial registry maintained by the National Library of Medicine. NCT00005603 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.