Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT00049075
Last Updated: 2020-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2002-08-08
2009-12-21
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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fludarabine phosphate
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
120 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Ralph M. Meyer, MD, FRCPC
Role: STUDY_CHAIR
Margaret and Charles Juravinski Cancer Centre
Locations
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Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Algoma Reginal Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Humber River Regional Hospital - Weston
Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Centre Jean Bernard
Le Mans, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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References
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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.
Other Identifiers
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CAN-NCIC-CL2
Identifier Type: OTHER
Identifier Source: secondary_id
BRLX-304160
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000257836
Identifier Type: OTHER
Identifier Source: secondary_id
CL2
Identifier Type: -
Identifier Source: org_study_id
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