NCT00002592

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow 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
40

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jun 1993

Longer than P75 for phase_2 leukemia

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1993

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 26, 2004

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

9.2 years

First QC Date

November 1, 1999

Last Update Submit

January 13, 2015

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

  • Number of Adberse Events

Interventions

c-myb antisense oligonucleotide G4460BIOLOGICAL
filgrastimBIOLOGICAL
busulfanDRUG
cyclophosphamideDRUG
autologous bone marrow transplantationPROCEDURE
in vitro-treated bone marrow transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically and cytologically proven chronic myelogenous leukemia Accelerated phase OR Chronic phase No hypocellular marrow (less than 25% cellularity) No patients under age 55 with a HLA-matched sibling donor PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: 0-1 Hematopoietic: Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction normal No significant cardiac disease requiring digoxin, diuretics, antiarrhythmics, or antianginal medications Pulmonary: PFTs normal DLCO normal Other: No persistent infection requiring antibiotics No concurrent organ damage or medical problem that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior interferon therapy Chemotherapy: Not specified 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 Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated Phase

Interventions

LR 3001FilgrastimBusulfanCyclophosphamide

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 FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Selina M. Luger, MD

    Abramson Cancer Center at Penn Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 26, 2004

Study Start

June 1, 1993

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

US(1)