Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study
ISRCTN | ISRCTN23153249 |
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DOI | https://doi.org/10.1186/ISRCTN23153249 |
EudraCT/CTIS number | 2006-000053-22 |
ClinicalTrials.gov number | NCT00458523 |
Secondary identifying numbers | UKCLL07 |
- Submission date
- 06/01/2006
- Registration date
- 20/01/2006
- Last edited
- 29/03/2022
- 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
Dr Peter Hillmen
Scientific
Scientific
Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)113 392 3766 |
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peter.hillmen@nhs.net |
Study information
Study design | Multi-centre open-label single-arm study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled 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 | Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study |
Study acronym | UKCLL07 |
Study objectives | 1. Is alemtuzumab effective and safe at treating patients with CLL whose disease is present at a low level following conventional treatments? 2. There will also be an investigation where MRD negative patients are monitored and retreated when necessary. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Chronic lymphocytic leukaemia (CLL) |
Intervention | Patients who have previously achieved a minimal residual disease (MRD) negative remission and have relapsed at a molecular level, or who have a low level of MRD following conventional therapy will receive treatment for a minimum of 6 weeks (3 times per week) and a maximum of 12 weeks. Patients who have achieved an MRD negative state by conventional therapy may register for the study but will not be treated with alemtuzumab until CLL becomes detectable again. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Alemtuzumab |
Primary outcome measure | 1. Rate of achieving MRD negativity in patients with low levels of MRD following conventional therapy or who relapse at an MRD level after a previous MRD negative remission 2. Safety of alemtuzumab in the MRD positive setting |
Secondary outcome measures | 1. Clinical response to alemtuzumab therapy by National Cancer Institute (NCI) Criteria 2. Overall survival 3. Pharmacokinetic profile of alemtuzumab in the MRD setting 4. Safety and efficacy of repeated dosing as required to achieve sustained MRD negativity Outcome of additional Monitoring Investigation (patients who are MRD negative at registration): 1. Time to MRD relapse 2. Effect of alemtuzumab used in a consolidation/maintenance approach on the expression of CD52 on CLL cells |
Overall study start date | 01/03/2006 |
Completion date | 29/02/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 54 |
Total final enrolment | 47 |
Key inclusion criteria | 1. At least 18 years old 2. Written informed consent 3. Previous confirmation of B-cell CLL with a characteristic immunophenotype on peripheral blood flow cytometry 4. Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis 5. Must have achieved a complete remission or good partial remission after therapy for CLL 6. At least six months since completing last therapy for CLL 7. Have detectable MRD, as shown by peripheral blood or bone marrow involvement or have attained an MRD negative remission. The latter group is eligible for registration and three-monthly monitoring for MRD relapse |
Key exclusion criteria | 1. Lymph nodes of 2 cm or greater in maximum diameter 2. Known Human Immunodeficiency Virus (HIV) positive 3. Active infection 4. Past history of anaphylaxis following exposure to rat or mouse derived Commonly Deleted Region (CDR)-grafted humanised monoclonal antibodies 5. Use of prior investigational agents within six weeks 6. Pregnancy or lactation 7. Central Nervous System (CNS) involvement with CLL 8. Mantle cell lymphoma 9. Other severe, concurrent diseases or mental disorders 10. Active secondary malignancy 11. Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l) 12. Patients previously treated with allogeneic Stem Cell Transplantation (SCT) 13. Patients who previously failed alemtuzumab therapy |
Date of first enrolment | 01/03/2006 |
Date of final enrolment | 29/02/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Research and Development
Leeds Teaching Hospitals NHS Trust
6th Floor Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
England
United Kingdom
https://ror.org/00v4dac24 |
Funders
Funder type
Industry
Schering Health Care Ltd (funding reference no. UKCLL07)
No information available
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 | 01/02/2017 | Yes | No | |
Plain English results | 10/07/2017 | 29/03/2022 | No | Yes |
Editorial Notes
29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
19/03/2020: EudraCT number added.
26/06/2017: Publication reference added.