E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 18.0 |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•To examine the efficacy of IPI-145 monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with ofatumumab in Study IPI-145-07
•To examine the efficacy of ofatumumab monotherapy in subjects who experienced disease progression after treatment with IPI 145 or ofatumumab in Study IPI-145-07
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E.2.2 | Secondary objectives of the trial |
•To determine the safety of IPI-145 and ofatumumab in subjects with CLL and SLL who experienced disease progression after treatment with IPI 145 in Study IPI-145-07 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Received either IPI 145 or ofatumumab while participating in Study IPI 145-07 and experienced radiologic disease progression
2.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008
criteria for requiring treatment
3. Must have received at least one prior therapy for CLL/SLL
4. Measureable nodal disease by CT
5. ECOG performance status of 0-2
6. Considered not appropriate for treatment or retreament with purine
analog-based therapy
7. Cytogenetics or Fish performed within 24 months prior to
randomization
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E.4 | Principal exclusion criteria |
Subjects are to be excluded from the study if they meet any of the following criteria:
1.Discontinued participation in Infinity-sponsored IPI-145-07 study for reasons other than disease progression
2.History of Richter's transformation or prolymphocytic leukemia
3. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP)
4.Prior allogeneic transplant
5.Known central nervous system (CNS) lymphoma or leukemia
6. Previous treatment with a PI3K inhibitor
7. Tyrosine kinase inhibitor within 7 days of randomization
8.Ongoing systemic bacterial, fungai, or viral infections at the time of
treatment
9. Unable to receive prophylactic treatment for pneumocytosis or herpes
simplex virus
10. History of tuberculosis within preceding two years
11.Prior, current or chronic hepatitis B or hepatitis C infection
12.History of stroke, unstable angina, myocardial infarction, or
ventricular arrhythmia requiring medication or mechanical control within
the last 6 months |
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E.5 End points |
E.5.1 | Primary end point(s) |
•ORR, CR, CRi, PR, nodular PR, or PR with lymphocytosis, Response Criteria, with modification for treatment-related lymphocytosis |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• TEAEs and changes in safety laboratory values
• OS defined as time from randomization to death
• ORR defined as a CR,Cri, PR, nPR, or PR with lymphocytosis; hematologic improvements |
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E.5.2 | Secondary end point(s) |
•TEAEs and changes in laboratory values
•DOR, defined as the time from the date of the first confirmed response to the first documentation of relapse or PD, whichever occurs first for all subjects by treatment arm
•Evaluation of PFS, defined as the time from the date of the first dose of study treatment to the first documentation of PD or death due to any cause for all subjects by treatment arm
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
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 |
Australia |
Austria |
Belgium |
France |
Germany |
Hungary |
Italy |
New Zealand |
Spain |
United Kingdom |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |