CLL6 (Roche): a randomised, phase II trial of fludarabine, cyclophosphamide and rituximab (FCR) with or without mitoxantrone in previously untreated chronic lymphocytic leukaemia
ISRCTN | ISRCTN42165735 |
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DOI | https://doi.org/10.1186/ISRCTN42165735 |
Secondary identifying numbers | HM08/8625 |
- Submission date
- 17/06/2008
- Registration date
- 02/10/2008
- Last edited
- 27/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Peter Hillmen
Scientific
Scientific
Department of Haematology
Level 3, Bexley Wing
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Phone | +44 (0)113 206 8513 |
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peter.hillmen@nhs.net |
Study information
Study design | Phase II multi-centre randomised controlled open parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | CLL6 (Roche): a randomised, phase II trial of fludarabine, cyclophosphamide and rituximab (FCR) with or without mitoxantrone in previously untreated chronic lymphocytic leukaemia |
Study acronym | CLL6 (Roche) |
Study objectives | The trial is intended to compare the complete remission rates of fludarabine, cyclophosphamide and rituximab (FCR) with or without mitoxantrone (M) in patients with previously untreated chronic lymphocytic leukaemia. |
Ethics approval(s) | Leeds (West) Research Ethics Committee, 09/02/2009, ref: 08/H1307/135 |
Health condition(s) or problem(s) studied | Chronic lymphocytic leukaemia (CLL) |
Intervention | This trial aims to recruit 218 patients over 18 months. Patients will be randomised to receive six cycles of either FCR or FCM-R. Cycles of FCR and FCM-R are reported every 28 days for a total of six courses. Each cycle is repeated every 28 days. However treatment is administered during each cycle as per the following schedule: Patients randomised to receive fludarabine, cyclophosphamide and rituximab (FCR) will receive: Fludarabine (oral): 24 mg/m^2/day on days 1 to 5 Cyclophosphamide (oral): 150 mg/m^2/day on days 1 to 5 Rituximab (IV): 375 mg/m^2 on day 1 (cycle 1) Rituximab (IV): 500 mg/m^2 on day 1 (cycle 2 to 6) Patients randomised to receive fludarabine, cyclophosphamide, rituximab and mitoxantrone (FCM-R) will receive: Fludarabine (oral): 24 mg/m^2/day on days 1 to 5 Cyclophosphamide (oral): 150 mg/m^2/day on days 1 to 5 Rituximab (IV): 375 mg/m^2 on day 1 (cycle 1) Rituximab (IV): 500 mg/m^2 on day 1 (cycle 2 to 6) Mitoxantrone (IV): 6 mg/m^2/day on day 1 |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Fludarabine, cyclophosphamide, rituximab, mitoxantrone |
Primary outcome measure | Proportion of patients achieving a complete response (CR) at three months post end-of-treatment as specified by the IWCLL criteria |
Secondary outcome measures | 1. Proportion of patients with undetectable minimal residual disease, measured at three months post-end-of-treatment 2. Overall response rate defined as complete or partial remission by the IWCLL criteria, measured at three months post-end-of-treatment 3. Progression free survival at two years 4. Overall survival at two years 5. Safety and toxicity, measured at two years after randomisation |
Overall study start date | 01/01/2009 |
Completion date | 01/07/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 218 |
Total final enrolment | 215 |
Key inclusion criteria | 1. Both males and females, at least 18 years old 2. B-cell chronic lymphocytic leukaemia (B-CLL) with a characteristic immunophenotype 3. Binet's Stages B, C or Progressive A 4. Requirement for therapy as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (must meet one of the following criteria: evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia) 5. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly 6. Massive nodes (i.e. 10 cm in longest diameter) or progressive or sypmtomatic lymphodenopathy 7. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30 x 10^9/L 8. A minimum of any one of the following disease-related symptoms must be present: 8.1. Unitentional weight loss more than or equal to 10% within the previous 6 months 8.2. Significant fatigue (i.e. Eastern Cooperative Oncology Group performance status 2 or worse; cannot work or unable to perform usual activities) 8.4. Fevers of greater than 38°C for two or more weeks without other evidence of infection 8.5. Night sweats for more than one month without evidence of infection 9. No prior therapy for CLL 10. Able to provide written informed consent |
Key exclusion criteria | 1. Prior therapy for CLL 2. Active infection 3. Past history of anaphylaxis following exposure to rat or mouse derived complementarity-determining regions (CDR)-grafted humanised monoclonal antibodies 4. Pregnancy, lactation or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment 5. Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile 6. Central nervous system (CNS) involvement with CLL 7. Mantle cell lymphoma 8. Other severe, concurrent disease or mental disorders 9. Known human immunodeficiency virus (HIV) positive 10. Patient has active or prior hepatitis B or C 11. Active secondary malignancy excluding basal cell lymphoma 12. Persisting severe pancytopenia (neutrophils less than 0.5 x 10^9/L or platelets less than 50 x 10^9/L), trasfusion dependent anaemia and active haemolysis 13. Patients with a creatinine clearance of less than 30 ml/min (either measured or derived by the Cockroft formula) |
Date of first enrolment | 01/06/2009 |
Date of final enrolment | 30/03/2012 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
St. James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development
Floor A/B - Old Site
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
England
United Kingdom
Phone | +44 (0)113 392 6473 |
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derek.norfolk@leedsth.nhs.uk | |
Website | http://www.leedsteachinghospitals.com |
https://ror.org/00v4dac24 |
Funders
Funder type
Industry
Roche
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
- Location
- Switzerland
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/10/2017 | Yes | No | |
Plain English results | 27/07/2022 | No | Yes | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.
26/06/2017: Publication reference added.