Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

NCT00049075 | Completed Phase 2 DMC

• 4 other identifiers: CL2CAN-NCIC-CL2BRLX-304160CDR0000257836
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 34

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.

Conditions

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

Interventions

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (34)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Providence Health Care - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Durham Regional Cancer Centre at Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Algoma Reginal Cancer Program at Sault Area Hospital

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

St. Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital - Weston

Weston, Ontario, M9N 1N8, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L 4MI, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Hopital de L'Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Hopital du Saint-Sacrement, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Related 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: 10.1038/leu.2009.205. Epub 2009 Oct 8. No abstract available.

  PMID: 19812607 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ralph M. Meyer, MD, FRCPC

  Margaret and Charles Juravinski Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: August 8, 2002
• Primary Completion: July 22, 2005
• Study Completion: December 21, 2009
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (32); FR (2)