NCT00002868

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for phase_3 leukemia

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6.3 years

First QC Date

November 1, 1999

Last Update Submit

June 21, 2023

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
busulfanDRUG
cytarabineDRUG
etoposideDRUG
hydroxyureaDRUG
idarubicinDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Newly diagnosed chronic myelogenous leukemia in chronic phase Philadelphia chromosome and/or BCR/ABL positive Initial diagnosis within 6 months of randomization No clinical or laboratory evidence of acceleration or blastic disease No contraindication to peripheral blood cell stem cell collection prior to treatment PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No major organ impairment Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa Chemotherapy: Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Riverview Medical Center - Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-Phase

Interventions

FilgrastimInterferon-alphaBusulfanCytarabineEtoposideHydroxyureaIdarubicinPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesUreaAmidesDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ian M. Franklin, MB, PhD

    Royal Infirmary - Castle

    STUDY CHAIR

  • Hillard M. Lazarus, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

November 20, 1997

Primary Completion

March 1, 2004

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(2)GB(1)