Plain English Summary
http://www.cancerhelp.org.uk/trials/-trial-looking-at-ofatumumab-for-mantle-cell-lymphoma
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Sheila Bullard
ORCID ID
Contact details
Lymphoma Trials Unit
N14
ITTC Building
Tamar Science Park
Derriford
Plymouth
PL6 8BX
United Kingdom
+44 (0)1752 437513
sheila.bullard@phnt.swest.nhs.uk
Additional identifiers
EudraCT number
2009-017675-16
ClinicalTrials.gov number
Protocol/serial number
9760
Study information
Scientific title
Multicentre non-randomised interventional treatment phase II trial of single agent ofatumumab in relapsed/refractory mantle cell lymphoma
Acronym
Ofatumumab Study
Study hypothesis
This is an open-label, phase II study of single agent ofatumumab in patients who have received one or more prior therapies for mantle cell lymphoma. This is a multicentre trial co-ordinated by the Plymouth Lymphoma Trials Unit, and sponsored by Plymouth Hospitals NHS Trust.
34 evaluable patients will receive single agent ofatumumab. This will be given as an intravenous infusion once a week for 5 weeks. The initial treatment of 300 mg will be commenced slowly starting at 12 ml/h, rising every 30 minutes to a maximum of 400 ml/h if no infusional reactions occur. Subject to patient tolerability, this dose and dose rate will be increased for subsequent infusions. A premedication of paracetamol, chlorphenamine (Piriton®) and prednisolone will be required prior to each infusion.
Response assessments will be performed 30 days after the final treatment and repeated after a further 3 months. Subsequent assessments will be performed as clinically required.
Ethics approval
South West 3 REC, 30/11/2010, ref: 10/H0106/66
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: Lymphoma; Disease: Lymphoma (non-Hodgkin's)
Intervention
An ofatumumab infusion will be given once a week for 5 weeks. The initial infusion will be 300 mg, the four subsequent infusions will be 1000 mg each, subject to tolerability and toxicity.
This is a single arm study, with all patients being treated with Ofatumumab. After treatment, they will be followed for disease progression and survival.
Study entry: registration only
Intervention type
Drug
Phase
Phase II
Drug names
Ofatumumab
Primary outcome measure
To evaluate the rates of overall response to ofatumumab in terms of complete response (CR).
When 9 evaluable patients have received Ofatumumab an interim analysis will be performed. If two or more patients respond the trial will continue until a further 25 evaluable patients have received the research treatment.
Secondary outcome measures
1. Disease progression
2. Liver toxicity
3. Other unacceptable toxicity
4. Withdrawal of patient consent
When 9 evaluable patients have received Ofatumumab an interim analysis will be performed. If two or more patients respond the trial will continue until a further 25 evaluable patients have received the research treatment.
Overall trial start date
17/01/2011
Overall trial end date
17/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female patients over the age of 18 years
2. A confirmed diagnosis of MCL including expression of cyclin D1 or evidence of t(11;14), by cytogenetics, fluorescent in situ hybridisation (FISH) or polymerase chain reaction (PCR)
3. Relapse/refractory MCL following the completion of a minimum of one previous course of cytotoxic chemotherapy treatment
4. All previous chemotherapy regimens are permissible (including those containing Rituximab)
5. Measurable disease
6. World Health Organization (WHO) score of 0 - 2
7. Absolute neutrophil count greater than or equal to 500 cells/µL not related to lymphoma
8. Platelets greater than or equal to 30,000 cells/µL not related to lymphoma
9. Toxic effects of previous therapy or surgery resolved to Grade 2 or better (with the exception of the haematological parameters discussed above)
10. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 34; UK sample size: 34
Participant exclusion criteria
1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
2. Anti-neoplastic therapy within 3 weeks before Day 1
3. Nitrosoureas within 6 weeks before Day 1
4. Radiation therapy within 3 weeks before Day 1
5. Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within three months before Day 1
6. Major surgery within 2 weeks before Day 1
7. Active systemic infection requiring treatment
8. Previous treatment or suspected hypersensitivity to Ofatumumab
9. Any concurrent active malignancy within the last 5 years patients who have a history of completely resected Non-melanoma skin cancer or in-situ carcinoma are eligible
10. Aspartate transaminase greater than 2.5 x upper limit of normal (ULN), or alanine transaminase greater than 2.5 x ULN, alkaline phosphatase greater than 2.5 x ULN unless due to disease involvement of the liver or bone
11. Total bilirubin greater than 1.5 x ULN unless due to liver involvement with MCL or known history of Gilbert's disease
12. Serum creatinine greater than 2.0 x ULN (unless normal creatinine clearance)
13. Female subject is pregnant or breast-feeding; confirmation of this will be required for female patients of child-bearing potential. For the purpose of this study, female of child-bearing potential is defined as women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
14. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
15. Moderate or severe Chronic Obstructive Pulmonary Disease
16. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
17. Treatment with another investigational agent for at least four weeks prior to enrolment into this study. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study.
18. Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease. Patients with these conditions may be included subject to PI assessment).
Recruitment start date
17/01/2011
Recruitment end date
17/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lymphoma Trials Unit
Plymouth
PL6 8BX
United Kingdom
Sponsor information
Organisation
Plymouth Hospitals NHS Trust (UK)
Sponsor details
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24666179