CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 350 enrolled
Drug / intervention
asparaginase +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00070174
NCT00070174Phase 2Completed

Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

Children's Oncology Group·interventional·Posted Oct 7, 2003·Updated Feb 20, 2014

In Brief

A Phase 2 clinical trial evaluating asparaginase, busulfan, and 9 other interventions for Leukemia. Completed, enrolled 350 participants across 148 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Canada, Puerto Rico, Switzerland, United States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2003
Enrollment StartDec 1, 2003
Primary CompletionSep 1, 2006
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.7 years ago

Interventions

asparaginasedrug

busulfandrug

cyclophosphamidedrug

cyclosporinedrug

cytarabinedrug

daunorubicin hydrochloridedrug

etoposidedrug

gemtuzumab ozogamicindrug

methotrexatedrug

mitoxantrone hydrochloridedrug

allogeneic bone marrow transplantationprocedure