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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 November 2019 |
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Main ID: |
ISRCTN23736115 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia
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Scientific title:
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Third Medical Research Council Trial in Chronic Lymphomatic Leukaemia |
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Date of first enrolment:
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01/04/1990 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN23736115 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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D
Catovsky |
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Address:
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Royal Marsden Hospital
Fulham Road
SW3 6JJ
London
United Kingdom |
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Telephone:
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+44 (0)20 7352 8171 |
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Email:
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abc@email.com |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. All patients with B-cell chronic lymphoblastic leukaemia diagnosed by a persistent blood lymphocytosis (greater than 10 x 10^9/l) and bone marrow infiltration of at least 40% who require treatment
2. Previously untreated stage B and C disease
3. Stage A patients showing evidence of disease progression
4. Previously treated patients who:
4.1 Have not received an anthracycline or anthracenedione
4.2 Are not considered to be resistant to chlorambucil
4.3 Have relapsed off therapy and need further treatment because of disease progression
5. No concomitant treatment with any other cytotoxic or immunomodulatory therapy
6. No other life threatening disease
7. No medical contraindications to treatment protocols
Exclusion criteria: Patients who have another life threatening disease; they are not expected to complete the study treatment for other reasons; they are having concomitant treatment with any cytotoxic or immunomodulatory therapy; there is evidence of heart disease which would preclude treatment with anthracycline or they have not given informed consent.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Leukaemia (chronic)
Cancer
Chronic lymphomatic leukaemia
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Intervention(s)
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Following randomisation stage C patients only receive pre-treatment with prednisolone. Patients are then treated on one of two treatment regimens depending upon the initial randomisation:
1. Regimen A: Chlorambucil orally daily for 6 days. Cycle repeated every 28 days.
2. Regimen B: Epirubicin on day 1 followed by chlorambucil orally for 6 days. Cycle to be repeated every 28 days.
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Primary Outcome(s)
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Death and death related to CLL, response to treatment, toxicity and compliance
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/04/1995 |
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URL:
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