E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory Mantle Cell Lymphoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026800 |
E.1.2 | Term | Mantle cell lymphoma recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026801 |
E.1.2 | Term | Mantle cell lymphoma refractory |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the rates of overall response to Ofatumumab in terms of complete response, complete response uncomfirmed and partial response. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the duration of response - defined as being the time between the first documentation of response to the time of documented progression To determine the median time to progression (TTP) To dewtermine the median ocerall survival - defined as being the time from first administration of Ofatumumab until the date of death - from any cause To evaluate the toxicity and tolerability of the research treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•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
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E.4 | Principal exclusion criteria |
•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)
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E.5 End points |
E.5.1 | Primary end point(s) |
Disease progression Unacceptable toxicity withdrawal of patient consent |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |