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NCT00070174 · ClinicalTrials.gov registry record · Phase 2

Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

A Phase 2 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
350
Enrollment target

NCT00070174 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 350 participants.

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The verdict

NCT00070174, a Phase 2 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
350 participants
Enrollment target

Study Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.

Interventions

  • DRUG cyclophosphamide
  • DRUG cytarabine
  • DRUG busulfan
  • DRUG cyclosporine
  • DRUG asparaginase

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2003-12
Est. Completion 2013-12
Phase Phase 2

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT00070174

The ClinicalTrials.gov registry entry for NCT00070174 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 350 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.

NCT00070174 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00070174 about?

NCT00070174 is a clinical study titled "Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy". RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or ...

What is the current status of trial NCT00070174?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2003-12. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00070174?

The interventions under investigation include: cyclophosphamide (DRUG), cytarabine (DRUG), busulfan (DRUG), cyclosporine (DRUG), asparaginase (DRUG).

Who is sponsoring clinical trial NCT00070174?

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.