Contact information
Type
Scientific
Primary contact
Dr Peter Hillmen
ORCID ID
Contact details
Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 3766
peter.hillmen@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00458523
Protocol/serial number
UKCLL07
Study information
Scientific title
Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study
Acronym
UKCLL07
Study hypothesis
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
Not provided at time of registration
Study design
Multi-centre open-label single-arm study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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 names
Alemtuzumab
Primary outcome measures
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 trial start date
01/03/2006
Overall trial end date
29/02/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
29/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Funders
Funder type
Industry
Funder name
Schering Health Care Ltd (funding reference no. UKCLL07)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28032335