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S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT00049179 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-03-06

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

Conditions

Interventions

DRUG

cytarabine

ind and consol: 200 mg/m2/d continuous IV days 1-7

DRUG

gemtuzumab ozogamicin

ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • John E. Godwin, MD, MS · Loyola University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2005-12-31
Completion
2010-10-31

Countries

  • United States

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 NCT00049179 on ClinicalTrials.gov