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NCT00075725 · ClinicalTrials.gov registry record · Phase 3

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

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

Completed
Registry status
Phase 3
Development phase
3,154
Enrollment target

NCT00075725 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 3,154 participants.

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The verdict

NCT00075725, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
3,154 participants
Enrollment target

Study Summary

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin Hydrochloride
  • DRUG Dexamethasone
  • DRUG Cytarabine
  • DRUG Daunorubicin Hydrochloride

Trial Details

FieldValue
Enrollment Target 3,154 participants
Start Date 2003-12-29
Est. Completion 2021-03-31
Phase Phase 3

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT00075725

The ClinicalTrials.gov registry entry for NCT00075725 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

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

NCT00075725 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00075725 about?

NCT00075725 is a clinical study titled "Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia". This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients...

What is the current status of trial NCT00075725?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,154 participants. The study started on 2003-12-29. Estimated completion is 2021-03-31.

What interventions are being tested in trial NCT00075725?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00075725?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.