E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsed or refractory Chronic Lymphocytic Leukemia |
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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 | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
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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 |
Phase I, Dose escalation • determination of the maximum tolerated dose (MTD) of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia (B-CLL). Phase II, Efficacy • evaluation of the preliminary efficacy of FBTA05 in patients with relapsed or refractory chronic lymphocytic leukemia with regard to objective response rate (CR, PR)
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E.2.2 | Secondary objectives of the trial |
Evaluation of safety and pharmacokinetic and pharmacodynamic relationship of the drug, and 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 |
Patients will be enrolled in this study only if they meet all of the following criteria: • Signed and dated informed consent form. • Male or female • > = 18 years of age • Confirmed B-CLL based on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies • CD20+ (if not already confirmed) • Relapsed/refractory active disease after at least two prior treatments requiring further therapy • Eastern Cooperative Oncology Group (ECOG) performance score of < = 2 • Adequate hematological, liver and kidney function: • Platelet count > = 25,000/mm³ (= 25 x 10^9/l) • Serum glutamic oxaloacetic transaminase (SGOT/aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) < = 2.5 x upper limit of normal (ULN) • Total bilirubin < = 1.5 x ULN • Creatinine < = 1.5 x ULN • 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)
In addition, the following therapies must be discontinued at the given time points: • Alemtuzumab, Rituximab or autologous stem transplantation must be discontinued at least 3 months prior to Visit 1 • Any anti-cancer therapy must have been discontinued at least 4 weeks prior to Visit 1
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E.4 | Principal exclusion criteria |
Patients will not be enrolled in this study if they meet any of the following criteria: • Women who are pregnant or breast feeding. • Known active HIV infection. • AIDS related lymphoma • Leptomeningeal involvement • Unable or unwilling to comply fully with the protocol • History of allogeneic stem cell transplantation • Second active malignant disease, currently requiring treatment (not including basal cell carcinoma or curative surgery treated tumor) • Documented acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled • Known or suspected hypersensitivity to recombinant/murine proteins • Any autoimmune disease • History of respiratory insufficiency • Patients participating in a concurrent clinical trial or treated with experimental therapy within 30 days prior to the first administration of FBTA05 • Clinical conditions equal to protocol definitions of DLT • Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study • Patients put into an institution by the authorities of judicial court |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint in Phase I, dose escalation, is the incidence of dose limiting toxicities (DLTs).
The primary endpoint in Phase II, efficacy, is the objective response rate (ORR).
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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 | 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 | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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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 | 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |