Phase II Trial of Single Agent Ofatumumab in Relapsed / Refractory Mantle Cell Lymphoma - Ofatumumab Study
- Conditions
- Relapsed or refractory Mantle Cell LymphomaMedDRA version: 14.1 Level: PT Classification code 10026800 Term: Mantle cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10026801 Term: Mantle cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-017675-16-GB
- Lead Sponsor
- Plymouth Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
•Male or female patients over the age of 18 years
•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)
•Relapse/refractory MCL following the completion of a minimum of one previous course of cytotoxic chemotherapy treatment.
•All previous chemotherapy regimens are permissible (including Rituximab)
•Measurable disease
•Karnofsky Performance Status (KPS) ?50% (ECOG 0-2)
•Absolute neutrophil count ? 500 cells/?L not related to lymphoma
•Platelets ?30,000 cells/?L not related to lymphoma
•Toxic effects of previous therapy (with the exception of any haematological toxicities as above) or surgery resolved to Grade 2 or better
•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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Known serological positivity for HBV, HCV or HIV
•Anti-neoplastic therapy within 3 weeks before Day 1
•Nitrosoureas within 6 weeks before Day 1
•Radiation therapy within 3 weeks before Day 1
•Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within 4 weeks before Day 1
•Major surgery within 2 weeks before Day 1
•Active systemic infection requiring treatment
•Previous treatment or suspected hypersensitivity to Ofatumumab
•Any concurrent active malignancy within the last 5 years
•Aspartate transaminase >3.0 x upper limit of normal (ULN), or alanine transaminase >3.0 x ULN unless due to liver involvement with MCL
•alkaline phosphatase >3.0 x ULN
•total bilirubin >2.0 x ULN unless due to liver involvement with MCL
•serum creatinine > 2.0 x ULN (unless normal creatinine clearance)
•Female subject is pregnant or breast-feeding; confirmation of this will be required for female patients of child-bearing potential.
•Moderate or severe Chronic Obstructive Pulmonary Disease
•Serious medical or psychiatric illness likely to interfere with participation in this clinical study
•Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study
•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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the rates of overall response to Ofatumumab in terms of complete response, complete response uncomfirmed and partial response.;<br> Secondary Objective: To evaluate the duration of response - defined as being the time between the first documentation of response to the time of documented progression<br> To determine the median time to progression (TTP)<br> To dewtermine the median ocerall survival - defined as being the time from first administration of Ofatumumab until the date of death - from any cause<br> To evaluate the toxicity and tolerability of the research treatment<br> ;<br> Primary end point(s): Disease progression<br> Unacceptable toxicity<br> withdrawal of patient consent<br>
- Secondary Outcome Measures
Name Time Method