MedTrace Logo

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

NCT00049517 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2023-06-15

Study results available
· View outcomes & findings →

Summary

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Conditions

Interventions

BIOLOGICAL

sargramostim

Given IV or as an injection

DRUG

busulfan

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Given as a continuous infusion

DRUG

gemtuzumab ozogamicin (GO)

Given IV

DRUG

Daunorubicin

Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

PROCEDURE

Autologous HCT

Autologous hematopoietic cell transplantation

PROCEDURE

Allogeneic HCT

Allogeneic hematopoietic cell transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Hugo F. Fernandez, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-19
Primary Completion
2009-03-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States
  • Israel

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 NCT00049517 on ClinicalTrials.gov