Contact information
Type
Scientific
Primary contact
Ms Stacey Gerard
ORCID ID
Contact details
Bone Marrow Transplant Unit
10th Floor
Prescot Street
Liverpool
L7 8XP
United Kingdom
-
Stacey.Gerard@rlbuht.nhs.uk
Additional identifiers
EudraCT number
2005-003729-18
ClinicalTrials.gov number
NCT00292760
Protocol/serial number
2514
Study information
Scientific title
Single-arm phase II to evaluate the safety and efficacy of Campath in combination with high-dose methylprednisolone in CLL patients with deletion of the p53 tumour suppressor gene.
Acronym
UKCLL206 (CAM-PRED)
Study hypothesis
A single-arm phase II study of alemtuzumab and high-dose methylprednisolone (Cam-Pred) in chronic lymphocytic leukaemia (CLL) patients with P53 deletion. The objectives are to assess the safety and efficacy of the combination of alemtuzumab and high-dose methylprednisolone in CLL patients with P53 deletion. this is a phase II open label study of untreated or previously treated patients with CLL or small lymphocytic lymphoma (SLL), whose CLL clone has a P53 gene deletion.
Ethics approval
MREC, 18/12/2005, ref: 05/MRE04/64
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (chronic)
Intervention
1. Beta2M
2. Buccal smear for comparison with tumour-cell DNA and 'tissue banking
3. Chest x-ray
4. Cytomegalovirus (CMV) serology and quantitative polymerase chain reaction (PCR) (or antigen testing according to local practice)
5. Coombs test
6. Computed tomography (CT) scan of neck, chest, abdomen and pelvis
7. EDTA: a 'first-pull' bone marrow aspirate sample should be collected in EDTA
8. Full blood count (FBC)
9. Lactate dehydrogenase (LDH)
10. P53 analysis, 50 ml blood for P53 analysis and 'tissue banking', plus a 5ml EDTA sample for diagnosis and morphological assesment
11. Pregnancy testing (if female and of child bearing potential)
12. Reticulocyte count
12. Serum immunoglobulins and electroporhesis
13. Bone marrow trephine biopsy
14. Urea and electrolytes (U&Es), liver function tests (LFTs), blood glucose and uric acid
Intervention type
Drug
Phase
Phase II
Drug names
Alemtuzumab, methylprednisolone
Primary outcome measure
Response rate (partial response [PR] and complete response [CR]) and MRD negativity rate achieved by the combinaton of alemtuzumab and high dose methylprednisolone
Secondary outcome measures
Safety of Cam-Pred in P53 deleted CLL
Overall trial start date
19/06/2006
Overall trial end date
13/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 18 years old, either sex
2. Written informed consent
3. Confirmed diagnosis of CLL or SLL (small mature lymphocytes in blood, bone marrow or lymph node expressing CD19, CD5, CD23, weak CD79b, and weak clonally restricted immunoglobulin light chain)
4. p53 deletion by FISH in at least 20% of leukaemia cells
5. Treatment is indicated (Binet stage B or C, or stage A with a lymphocyte doubling time of less than 6 months, or disease-related symptoms or complications irrespective of clinical stage)
6. World Health Organization (WHO) performance status 0, 1 or 2
7. Both untreated and previously treated patients are eligible for study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 40; UK sample size: 40
Participant exclusion criteria
1. Active infection
2. Known human immunodeficiency virus (HIV) infection
3. Past history of anaphylaxis following exposure to rat or mouse CDR-grafted humanised monoclonal antibodies
4. Less than 3 weeks since prior chemotherapy
5. Use of prior investigational agents within 6 weeks
6. Pregnancy or lactation
7. Uncontrolled diabetes mellitus
8. Uncontrolled hypertension
9. Active peptic ulcer disease
10. Other severe concurrent diseases or mental disorders
11. Serum urea or creatinine more than twice the upper limit of normal (unless due to ureteric obstruction or renal infiltration by CLL/SLL)
12. Serum bilirubin more than twice the upper limit of normal (unless due to haemolysis or liver infiltration with CLL/SLL)
13. Persisting severe cytopenias due to previous therapy rather than disease (neutrophils less than 0.5 x 10^9/l or platelets less than 50 x 10^9/l)
Recruitment start date
19/06/2006
Recruitment end date
13/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
-
Liverpool
L69 3BX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C18029/A5921)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22493413