E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029547 |
E.1.2 | Term | Non-Hodgkin's lymphoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
|
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 determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL paitent and to confirm safety and efficacy of veltuzumab that was previously established when administered intravenously. |
|
E.2.2 | Secondary objectives of the trial |
To document the safety, tolerance and lack of immunogenicity of veltuzumab with this route of administration and to assess pharmacodynamics, pharmacokinetics, and to document evidence of efficacy in these patient groups |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
histologically confirmed diagnosis of CD20+ follicular, small lymphocytic lymphoma or marginal zone NHL or CLL; either previously untreated or relapsed; male or female, age 18 years or older; adequate performance status with an estimated life expectancy of at least 6 months; patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last infusion; women of childbearing potential must have a negative urine or serum pregnancy test; sign EC-approved informed consent |
|
E.4 | Principal exclusion criteria |
previously untreated NHL patient with Stage I and II disease; previously untreated CLL patients with Stage 0-2 disease unless specific treatment indications by NCCN guidelines exist; relapsed patients receiving more than 4 prior treatment regimens; known central nervous system involvement by lymphoma, HIV lymphoma, transformed lymphoma; prior malignancies unless disease free for 5 years; rituximab resistant |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy endpoints will be evaluated using CT-based International Working Group (Cheson) criteria for NHL patients and hematolgoy based NCI criteria for CLL patients; Safety evaluations include monitoring for injection reactions or other adverse events, vital signs, physical examination, and safety laboratories, including hematology, T-cell levels, serum immunoglobulins, etc. Immunogenicity will be evaluated from serum samples; Pharmacodynamics will be evaluated from changes in circulating B-cell levels from baseline values; Pharmacokinetics will be evaluated from serum samples |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |