Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

NCT00005962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-22

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. 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. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia.

PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.

Conditions

Interventions

BIOLOGICAL

sargramostim

DRUG

cytarabine

DRUG

gemtuzumab ozogamicin

DRUG

liposomal daunorubicin citrate

DRUG

topotecan hydrochloride

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Mark R. Litzow, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-04
Primary Completion
2005-10-31
Completion
2007-06-30

Countries

  • United States
  • Puerto Rico
  • South Africa

Study Locations

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Entities

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 NCT00005962 on ClinicalTrials.gov