Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049075
• Other study ID #: CL2
• Secondary ID: CAN-NCIC-CL2BRLX
• Status: Completed
• Phase: Phase 2
• Start date: August 8, 2002
• Est. completion date: December 21, 2009

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 21, 2009
• Est. primary completion date: July 22, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• fludarabine phosphate

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
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	Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Durham Regional Cancer Centre at Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Hopital de L'Enfant Jesus	Quebec City	Quebec
Canada	Hopital du Saint-Sacrement, Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Algoma Reginal Cancer Program at Sault Area Hospital	Sault Sainte Marie	Ontario
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Providence Health Care - Vancouver	Vancouver	British Columbia
Canada	Humber River Regional Hospital - Weston	Weston	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
France	Centre Jean Bernard	Le Mans
France	Centre Hospitalier Lyon Sud	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (1)

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: — View Citation