E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory B-cell Non Hodgkin's Lymphoma. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and to determine the maximum tolerated dose (MTD), if reached, of TRU 015 in subjects with relapsed or refractory B cell NHL. |
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E.2.2 | Secondary objectives of the trial |
To characterize the pharmacokinetics (PK) of TRU 015 in subjects with B cell NHL. To characterize the pharmacodynamic (PD) response following TRU 015 treatment in subjects with B cell NHL. To evaluate the immunogenicity of TRU 015 in subjects with B cell NHL. To evaluate the clinical activity of TRU 015 in an expanded cohort of subjects with relapsed, refractory, or persistent follicular B cell NHL. To evaluate the pharmacogenetics (PGt) and the pharmacogenomics (PG) of subjects with B cell NHL receiving TRU 015.(exploratory) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with CD20-positive, B cell NHL who, after at least 2 prior therapies of probable clinical benefit, have relapsed or refractory disease.
With At least 1 measurable lesion that is 1.5 cm in at least 1 dimension by CT or magnetic resonance imaging (MRI), in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.
Patient with adequate bone marrow function, renal and adequate hepatic function. And Who have recovered to baseline or grade 1 [according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0] from all acute adverse effects of prior therapies (excluding alopecia).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (or 2, not declining within past 2 weeks). |
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E.4 | Principal exclusion criteria |
Candidate for potentially curative therapy that is available to the subject, in the clinical opinion of the investigator.
Diagnosis of chronic lymphocytic leukemia, Burkitt’s lymphoma, primary effusion lymphoma, and/or precursor B cell lymphoblastic lymphoma.
Who received previous radioimmunotherapy.
Allogeneic hematopoietic stem cell transplant within 6 months before the first dose of test article.
Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before the first dose of test article.
Major surgery, not related to debulking surgical procedures, within 3 weeks before the first dose of test article.
Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
Compromised immune system due to human immunodeficiency virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti-HCV], respectively). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety will be described by summary displays (descriptive statistics and graphs). DLT incidence and adverse event incidence will be described by dose level. The frequency of occurrence of overall toxicity will be summarized.
The antitumor activity will be evaluated on an exploratory basis and will be summarized using descriptive statistics or graphics. The objective response rate (complete response [CR] + partial response [PR]) among subjects will be summarized using descriptive statistics and estimated using an exact confident interval approach within each stratum and across all strata. Progression-free survival and overall survival will be evaluated using the Kaplan-Meier method. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
| |
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 |