NCT00002771

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow 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 various combination chemotherapy regimens or bone marrow transplantation in treating patients with chronic myelogenous leukemia.

Trial Health

55
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Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2000

First QC Date

November 1, 1999

Last Update Submit

August 1, 2013

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positivePhiladelphia chromosome negative chronic myelogenous leukemiachildhood chronic myelogenous leukemia

Interventions

recombinant interferon alfaBIOLOGICAL
busulfanDRUG
cytarabineDRUG
hydroxyureaDRUG
idarubicinDRUG
allogeneic bone marrow transplantationPROCEDURE
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

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- or bcr/abl-positive * Cytogenetic negativity (analyzed separately) allowed if at least 1 of the following criteria is met: * Malaise with decreased performance status * Weight loss of more than 10% within the past 6 months * Fever more than 38.5 C for 5 consecutive days * Symptomatic splenomegaly * Leukocyte count greater than 50,000/mm\^3 * Platelet count greater than 1,000,000/mm\^3 PATIENT CHARACTERISTICS: Age: * Any age Performance status: * See Disease Characteristics Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * No other medical condition that would reduce life expectancy * No other uncontrolled malignancy * Not pregnant * No other contraindication to study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon Chemotherapy: * No prior cytotoxic therapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy 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 (1)

III Medizinische Klinik Mannheim

Mannheim, D-68135, Germany

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Interferon-alphaBusulfanCytarabineHydroxyureaIdarubicinPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUreaAmidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ruediger Hehlmann, MD

    III. Medizinische Klinik Mannheim

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1995

Last Updated

August 2, 2013

Record last verified: 2000-07

Locations

DE(1)