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Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fludarabine phosphate
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute
  • Providence Health Care - Vancouver
  • CancerCare Manitoba
  • Moncton Hospital
  • Saint John Regional Hospital
  • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia Cancer Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Kingston Regional Cancer Centre
  • Grand River Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Credit Valley Hospital
  • Durham Regional Cancer Centre at Lakeridge Health Oshawa
  • Ottawa Regional Cancer Centre
  • Algoma Reginal Cancer Program at Sault Area Hospital
  • Hotel Dieu Health Sciences Hospital - Niagara
  • Northeastern Ontario Regional Cancer Centre, Sudbury
  • Northwestern Ontario Regional Cancer Centre, Thunder Bay
  • Toronto Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital
  • St. Joseph's Health Centre - Toronto
  • Humber River Regional Hospital - Weston
  • Cancer Care Ontario - Windsor Regional Cancer Centre
  • CHUS-Hopital Fleurimont
  • Hopital Charles Lemoyne
  • Maisonneuve-Rosemont Hospital
  • Centre Hospitalier de l'Universite de Montreal
  • McGill University
  • Hopital de L'Enfant Jesus
  • Hopital du Saint-Sacrement, Quebec
  • Allan Blair Cancer Centre
  • Centre Jean Bernard
  • Centre Hospitalier Lyon Sud

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00049075
Brief Title
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
Official Title
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2002 (Actual)
Primary Completion Date
July 22, 2005 (Actual)
Study Completion Date
December 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph M. Meyer, MD, FRCPC
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Providence Health Care - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6ZB
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Newfoundland Cancer Treatment and Research Foundation
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Durham Regional Cancer Centre at Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Algoma Reginal Cancer Program at Sault Area Hospital
City
Sault Sainte Marie
State/Province
Ontario
ZIP/Postal Code
P6B 1Y5
Country
Canada
Facility Name
Hotel Dieu Health Sciences Hospital - Niagara
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 5K3
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre, Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Northwestern Ontario Regional Cancer Centre, Thunder Bay
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 7T1
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
St. Joseph's Health Centre - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Humber River Regional Hospital - Weston
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
CHUS-Hopital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4MI
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hopital de L'Enfant Jesus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Hopital du Saint-Sacrement, Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19812607
Citation
Shustik C, Turner AR, Desjardins P, Fernandez L, Rubin S, Larratt L, Duncan AM, Rizi D, Sadura A, Shepherd L, Li D, Rassenti L, Kipps T. Oral fludarabine in untreated patients with B-cell chronic lymphocytic leukemia. Leukemia. 2010 Jan;24(1):237-9. doi: 10.1038/leu.2009.205. Epub 2009 Oct 8. No abstract available.
Results Reference
result

Learn more about this trial

Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

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