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 |
| EudraCT/CTIS number | 2005-003729-18 |
| ClinicalTrials.gov number | NCT00292760 |
| Secondary identifying numbers | 2514 |
- 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
Contact information
Ms Stacey Gerard
Scientific
Scientific
Bone Marrow Transplant Unit
10th Floor, Prescot Street
Liverpool
L7 8XP
United Kingdom
| Stacey.Gerard@rlbuht.nhs.uk |
Study information
| Study design | Multicentre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 19/06/2006 |
| Completion date | 13/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 40; UK sample size: 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
- England
- United Kingdom
Study participating centre
The Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Sponsor information
University of Liverpool (UK)
University/education
University/education
-
Liverpool
L69 3BX
England
United Kingdom
| Website | http://www.liv.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C18029/A5921)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 10/05/2012 | Yes | No |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
01/03/2016: Publication reference added.
