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

NCT00070174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2014-02-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

asparaginase

DRUG

busulfan

DRUG

cyclophosphamide

DRUG

cyclosporine

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

DRUG

etoposide

DRUG

gemtuzumab ozogamicin

DRUG

methotrexate

DRUG

mitoxantrone hydrochloride

PROCEDURE

allogeneic bone marrow transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Janet Franklin, MD, MPH · Children's Hospital Los Angeles

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-09-30
Completion
2013-12-31

Countries

  • United States
  • Australia
  • Canada
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00070174 on ClinicalTrials.gov