Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

April 2, 2020 updated by: NCIC Clinical Trials Group

A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine.
  • Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug.
  • Determine the progression-free and treatment-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug.
  • Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug.
  • Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy.

Patients are followed at 2 months and then every 4 months for 2 years.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Providence Health Care - Vancouver
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6ZB
        • Moncton Hospital
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • Durham Regional Cancer Centre at Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Regional Cancer Centre
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • Algoma Reginal Cancer Program at Sault Area Hospital
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences Hospital - Niagara
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre, Sudbury
      • Thunder Bay, Ontario, Canada, P7A 7T1
        • Northwestern Ontario Regional Cancer Centre, Thunder Bay
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre - Toronto
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital - Weston
      • Windsor, Ontario, Canada, N8W 2X3
        • Cancer Care Ontario - Windsor Regional Cancer Centre
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles Lemoyne
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2L 4MI
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrement, Quebec
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Hopital de L'enfant Jesus
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • France
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

    • Previously untreated
    • Rai stage I, II, III, or IV
    • Requiring systemic therapy

  • Persistent lymphocytosis of greater than 5,000/mm^3

    • Morphologically mature lymphocytes

  • Monoclonal B-cell population

    • CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping
  • No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome

  • No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia

    • Positive Coomb's test allowed if no clinical hemolysis

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and/or ALT no greater than 2 times ULN

Renal

  • Creatinine no greater than 2 times ULN

Other

  • Accessible for treatment and follow-up
  • No known HIV infection
  • No active bacterial, viral, or fungal infection requiring systemic antibiotics
  • No conditions requiring corticosteroid therapy

  • No history of other malignancies except for the following:

    • Adequately treated nonmelanoma skin cancer
    • Curatively treated carcinoma in situ of the cervix
    • Other solid tumors curatively treated with no evidence of disease within the past 5 years
  • No other major medical illness that would preclude study
  • No known hypersensitivity to fludarabine or its components
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy including monoclonal antibody therapy
  • No concurrent autologous or allogeneic stem cell or bone marrow transplantation

Chemotherapy

  • No other concurrent cytotoxic drugs

Endocrine therapy

  • No concurrent corticosteroids except inhaled or topical corticosteroids

    • No concurrent corticosteroids for nausea prophylaxis

Radiotherapy

  • No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2002

Primary Completion (Actual)

July 22, 2005

Study Completion (Actual)

December 21, 2009

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL2
  • CAN-NCIC-CL2 (Other Identifier: PDQ)
  • BRLX-304160 (Other Identifier: Berlex Study Number)
  • CDR0000257836 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on fludarabine phosphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe