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Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017108
First received: June 6, 2001
Last updated: July 23, 2008
Last verified: June 2004
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: chlorambucil
Drug: cyclophosphamide
Drug: fludarabine phosphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Low Dose Chlorambucil Maintenance Vs. No Treatment Following High-Dose Chlorambucil Induction In Patients With Advanced B-Chronic Lymphocytic Leukemia. A Randomized Phase III Study Of The EORTC LG (CLL-3)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

  • Compare overall and disease-related survival of patients with B-cell chronic lymphocytic leukemia treated with high-dose chlorambucil induction therapy with or without low-dose chlorambucil maintenance therapy.
  • Compare the time to salvage treatment in these patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the treatment-related mortality of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, time to complete response (before 12 weeks vs after 12 weeks vs partial response), and cytopenia at diagnosis (Binet stage A+B vs C).

All patients receive induction therapy comprising high-dose oral chlorambucil daily. Treatment continues until achievement of complete response or a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients who respond to induction therapy are randomized to 1 of 2 treatment arms for maintenance therapy.

  • Arm I: Patients receive low-dose oral chlorambucil twice a week. Therapy continues for up to 5 years in the absence of disease progression or unacceptable toxicity. If disease progression occurs, then patients may proceed to salvage therapy.
  • Arm II: Patients receive no maintenance therapy. If disease progresses, patients receive induction therapy again. If disease does not respond to re-induction therapy, then patients may proceed to salvage therapy.
  • Salvage therapy: Patients with progressive disease during maintenance therapy receive fludarabine IV daily and cyclophosphamide IV daily on days 1-3. Treatment repeats every 4 weeks for 3-6 courses.

Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 470 patients will be accrued for this study within 4.7 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017108

Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
Czech Republic
University Hospital - Olomouc
Olomouc, Czech Republic, 775 20
Hungary
County Hospital
Kaposvar, Hungary, H-7400
Italy
Azienda Ospedaliera Papardo
Messina, Italy
Ospedale Sant' Eugenio
Rome, Italy, 00144
Macedonia, The Former Yugoslav Republic of
Clinical Center Skopje
Skopje, Macedonia, The Former Yugoslav Republic of, 91000
Netherlands
Leyenburg Ziekenhuis
's-Gravenhage, Netherlands, 2545 CH
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Portugal
Hospital Escolar San Joao
Porto, Portugal, 4200
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Branimir Jaksic, MD, PhD University of Zagreb Medical School
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00017108     History of Changes
Other Study ID Numbers: CDR0000068650, EORTC-06992-CLL-3
Study First Received: June 6, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Chlorambucil
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014