NCT00002674

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Oct 1994

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1994

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 23, 2004

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

5.4 years

First QC Date

November 1, 1999

Last Update Submit

March 31, 2010

Conditions

Leukemia

Keywords

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

Interventions

filgrastimBIOLOGICAL
cytarabineDRUG
etoposideDRUG
hydroxyureaDRUG
mitoxantrone hydrochlorideDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic or accelerated phase Ineligible for allograft protocols or no available HLA-matched sibling marrow donor No patients under age 55 who have consented to unrelated donor search unless: Search unsuccessful for 6 months and unlikely a donor will be found Transplant from an unrelated donor declined No history of CML blast crisis No grade III/IV myelofibrosis PATIENT CHARACTERISTICS: Age: Over 17 to under 66 Performance status: Not specified Life expectancy: No limitations from disease other than leukemia Other: No hepatic, renal, pulmonary, or cardiac dysfunction that would preclude transplant preparative regimen No HIV antibody No active infection PRIOR CONCURRENT THERAPY: At least 1 month since interferon

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

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

Interventions

FilgrastimCytarabineEtoposideHydroxyureaMitoxantronePeripheral Blood Stem Cell Transplantation

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)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesUreaAmidesAnthraquinonesAnthronesAnthracenesQuinonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Leona A. Holmberg, MD, PhD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 23, 2004

Study Start

October 1, 1994

Primary Completion

March 1, 2000

Study Completion

March 1, 2000

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)