NCT00017108

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which chlorambucil regimen is more effective in treating advanced chronic lymphocytic leukemia. PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.

Trial Health

65
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Trial Health Score

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

Geographic Reach
7 countries

13 active sites

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

March 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 24, 2008

Status Verified

June 1, 2004

First QC Date

June 6, 2001

Last Update Submit

July 23, 2008

Conditions

Leukemia

Keywords

stage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemia

Interventions

chlorambucilDRUG
cyclophosphamideDRUG
fludarabine phosphateDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia * Co-expression of CD5/CD19 or CD5/CD20 positivity, dim sIg, and CD23 positivity * Previously untreated advanced disease defined as presence of at least 1 of the following: * Total tumor mass (TTM) score greater than 9 * TTM doubling time less than 12 months * Bone marrow failure (platelet count less than 100,000/mm\^3 and/or hemoglobin less than 10 g/dL) PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin less than 3 times upper limit of normal (ULN) * Hepatitis B negative * No active hepatitis C Renal: * Creatinine less than 3 times ULN OR * Creatinine clearance greater than 0.5 times normal Cardiovascular: * No severe cardiovascular disease * No arrhythmia requiring chronic treatment * No New York Heart Association class III or IV congestive heart failure * No symptomatic ischemic heart disease Other: * No uncontrolled systemic infection * HIV negative * No prior or concurrent uncontrolled malignancy * No prior or concurrent central nervous system or psychiatric disorders requiring hospitalization * No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior steroid therapy for less than 2 weeks allowed 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 (13)

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

Location

County Hospital

Kaposvár, H-7400, Hungary

Location

Azienda Ospedaliera Papardo

Messina, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Leyenburg Ziekenhuis

The Hague, 2545 CH, Netherlands

Location

Clinical Center Skopje

Skopje, 91000, North Macedonia

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

ChlorambucilCyclophosphamidefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramide MustardsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Branimir Jaksic, MD, PhD

    University of Zagreb Medical School

Study Design

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

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Last Updated

July 24, 2008

Record last verified: 2004-06

Locations

PT(1)HU(1)IT(2)CZ(1)NL(4)NO(1)BE(3)