E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) |
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E.1.1.1 | Medical condition in easily understood language |
Refractory Chronic Lymphocytic Leukemia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
E.1.2 | System Organ Class | 100000004864 |
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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 tolerability of Tenalisib as single agent or in combination until the withdrawal of subject from the study due to disease progression, unacceptable toxicity or any other reason including consent withdrawal or investigator’s decision.
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E.2.2 | Secondary objectives of the trial |
Time to disease progression |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must meet all inclusion criteria to be eligible for participation in this study: 1. Patients must be currently receiving treatment with Tenalisib either as monotherapy or in combination with another agent on a previously approved protocol for hematological malignancies including but not limited to indications DLBCL, iNHL, PTCL, CTCL, CLL and HL. 2. Patients must have had at least one efficacy evaluation following the initiation of Tenalisib in previous study and should have achieved either SD, PR or CR. 3. Patients must have completed at least 6 cycles of Tenalisib in previous study 4. Ability to swallow and retain oral medication. 5. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception throughout the study period and for 4 weeks after the last dose of Tenalisib. A barrier method of contraception must be included. 6. Male patients must be willing to use adequate contraceptive measures throughout the study period and for 12 weeks after the last dose of Tenalisib. 7. Willingness and ability to comply with trial and follow-up procedures. 8. Willingness to provide new written informed consent. |
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E.4 | Principal exclusion criteria |
Patients must meet none of the following exclusion criteria to be eligible for participation in this study: 1. Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial. 2. Patient progressed while receiving Tenalisib therapy in his/her previous study. 3. Pregnant or lactating woman. 4. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 5. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse Events (AEs), Grade 3/ 4 AEs and Serious Adverse Event (SAEs). Date of disease progression. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | No |
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 |
Bulgaria |
Georgia |
Poland |
United States |
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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
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The day of the last dose of study drug will be considered as EOT. |
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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 | 7 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |