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Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

NCT00002868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2023-06-22

No results posted yet for this study

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without peripheral stem cell transplantation in treating patients who have newly diagnosed chronic myelogenous leukemia in chronic phase.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

recombinant interferon alfa

DRUG

busulfan

DRUG

cytarabine

DRUG

etoposide

DRUG

hydroxyurea

DRUG

idarubicin

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Ian M. Franklin, MB, PhD · Royal Infirmary - Castle

  • Hillard M. Lazarus, MD · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-20
Primary Completion
2004-03-31

Countries

  • United States
  • United Kingdom

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 NCT00002868 on ClinicalTrials.gov