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AzTrials

LeukemiaPhase 2NCT00049075

Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing fludarabine phosphate in people with Leukemia, run by NCIC Clinical Trials Group at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Leukemia
What is being tested?
fludarabine phosphate
How many people
128 participants
Where
34 sitesin 2 countries
Study dates
8 Aug 2002to 21 Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

Canada32 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Durham Regional Cancer Centre at Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Hopital de L'Enfant Jesus

    Québec, Quebec, G1J 1Z4

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Algoma Reginal Cancer Program at Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

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

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Providence Health Care - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • Humber River Regional Hospital - Weston

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France2 sites

  • Centre Jean Bernard

    Le Mans, 72000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start8 Aug 2002
  3. Primary completion22 Jul 2005
  4. Study completion21 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049075
Sponsor's protocol ID
CL2
Other IDs
CAN-NCIC-CL2, BRLX-304160, CDR0000257836
Status last verified
Apr 2020
First submitted
12 Nov 2002
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19812607

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fludarabine phosphate in people with Leukemia, run by NCIC Clinical Trials Group at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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