Condition category
Cancer
Date applied
19/08/2010
Date assigned
19/08/2010
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.liv.ac.uk/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22493413

Publication citations

Additional files

Editorial Notes

01/03/2016: Publication reference added.