Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study

ISRCTN	ISRCTN23153249
DOI	https://doi.org/10.1186/ISRCTN23153249
ClinicalTrials.gov (NCT)	NCT00458523
Clinical Trials Information System (CTIS)	2006-000053-22
Protocol serial number	UKCLL07
Sponsor	Leeds Teaching Hospitals NHS Trust (UK)
Funder	Schering Health Care Ltd (funding reference no. 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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-alemtuzumab-after-chemotherapy-for-chronic-lymphocytic-leukaemia-cll207-mrd-eradication-study

Contact information

Dr Peter Hillmen
Scientific

Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 3766
Email	peter.hillmen@nhs.net

Study information

Primary study design	Interventional
Study design	Multi-centre open-label single-arm study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Alemtuzumab
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	29/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.