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.

ISRCTN	ISRCTN38006233
DOI	https://doi.org/10.1186/ISRCTN38006233
ClinicalTrials.gov (NCT)	NCT00292760
Clinical Trials Information System (CTIS)	2005-003729-18
Protocol serial number	2514
Sponsor	University of Liverpool (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C18029/A5921)

Submission date: 19/08/2010
Registration date: 19/08/2010
Last edited: 19/10/2018

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-into-alemtuzumab-and-methylprednisolone-for-people-with-chronic-lymphocytic-leukaemia-with-a-p53-gene-defect

Contact information

Ms Stacey Gerard
Scientific

Bone Marrow Transplant Unit
10th Floor, Prescot Street
Liverpool
L7 8XP
United Kingdom

Email	Stacey.Gerard@rlbuht.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional treatment trial
Secondary study design	Non randomised study
Study type	Participant information sheet
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.
Study acronym	UKCLL206 (CAM-PRED)
Study objectives	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(s)	MREC, 18/12/2005, ref: 05/MRE04/64
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Alemtuzumab, methylprednisolone
Primary outcome measure(s)	Response rate (partial response [PR] and complete response [CR]) and MRD negativity rate achieved by the combinaton of alemtuzumab and high dose methylprednisolone
Key secondary outcome measure(s)	Safety of Cam-Pred in P53 deleted CLL
Completion date	13/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key 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
Key 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)
Date of first enrolment	19/06/2006
Date of final enrolment	13/02/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Royal Liverpool University Hospital

Liverpool
L7 8XP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
01/03/2016: Publication reference added.