NCT00005986

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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

4.1 years

First QC Date

July 5, 2000

Last Update Submit

November 27, 2017

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemia

Interventions

busulfanDRUG
cyclophosphamideDRUG
filgrastimDRUG
recombinant interferon alfaDRUG
in vitro-treated peripheral blood stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia * Philadelphia chromosome positive OR * BCR/ABL rearrangement * No blast crisis or post blast crisis * No moderate to severe fibrosis defined by bilateral trephine biopsies * Not eligible for or refused to participate in allogeneic marrow transplant protocols * No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * Karnofsky 90-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Normal organ function (except bone marrow) PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior interferon alfa allowed Chemotherapy: * Prior hydroxyurea allowed * At least 2 months since prior busulfan (at time of PBSC harvest) 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 (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

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

Interventions

BusulfanCyclophosphamideFilgrastimInterferon-alphaPeripheral 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)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Catherine M. Verfaillie, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

February 12, 2004

Study Start

August 1, 2000

Primary Completion

September 1, 2004

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)