E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CD20 positive chronic lymphocytic leukemia (CLL) low and high grade non-Hodgkin´s lymphoma (NHL) |
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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 |
Phase I, Dose escalation - Determination of the maximum tolerated dose (MTD) of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL. Phase II, Efficacy - Evaluation of preliminary efficacy of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL with regard to objective response rates (CR, PR, SD). |
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E.2.2 | Secondary objectives of the trial |
Evaluation of safety and pharmacodynamic relationship of FBTA05 in context with DLI, the induction of cellular immunity in terms of Graft vs. Leukemia / Lymphoma effects (GvL) or Graft vs. Host disease (GvHD) and the determination of further efficacy data in terms of time to progression (TTP), duration of response and clinical benefit. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient´s written informed consent; - >18 years of age; male and female - Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies; - CD20 positivity (if not already confirmed); - Patients with relapsed / refractory disease that survived at least 60 days after allogeneic transplantation; - Eastern Cooperative Oncology Group (ECOG) performance status > 2 - Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre-menopausal, <2 years post-menopausal or not surgically sterile) |
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E.4 | Principal exclusion criteria |
- Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05; - Positivity for human anti-mouse antibodies (HAMAs); - History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day; - Known or suspected hypersensitivity to recombinant, murine or rat proteins; - Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Phase I, Dose escalation - Determination of the maximum tolerated dose (MTD) of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL. Phase II, Efficacy - Evaluation of preliminary efficacy of FBTA05 in combination with DLI in patients with CLL/low grade NHL and high grade NHL with regard to objective response rates (CR, PR, SD).
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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 | 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) | 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 | Information not present in EudraCT |
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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |