Study to assess the safety and efficacy of the study drug IPI-145 in Leukaemia patients compared with Ofatumumab

Conditions: Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002405-61-ES

Lead Sponsor: Infinity Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 307

Inclusion Criteria

1.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment
2. Must have received at least one prior therapy for CLL/SLL
3. Measureable nodal disease by CT
4. ECOG performance status of 0-2
5. Considered not appropriate for treatment or retreament with purine analog-based therapy
6. Cytogenetics or Fish performed within 24 months prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 207
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.History of Richter's transformation or prolymphocytic leukemia
2. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP)
3.Prior allogeneic transplant
4.Known central nervous system (CNS) lymphoma or leukemia
5. Previous treatment with a PI3K inhibitor
6. Tyrosine kinase inhibitor within 7 days of randomization
7.Ongoing systemic bacterial, fungai, or viral infections at the time of treatment
8. Unable to receive prophylactic treatment for pneumocytosis or herpes simplex virus
9. History of tuberculosis within preceding two years
10.Prior, current or chronic hepatitis B or hepatitis C infection
11.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL);Secondary Objective: To determine the safety of IPI-145 in subjects with CLL and SLL<br>To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s);Primary end point(s): PFS defined as time from randomization to the first documentation of progressive disease (PD) as determined by independent review or death due to any cause;Timepoint(s) of evaluation of this end point: Progression of disease or Death

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Overall survival;Secondary end point(s): TEAEs and changes in safety laboratory values <br>OS defined as time from randomization to death<br>Overall Response Rate (ORR) (based on independent<br>assessment), defined as a complete response/remission (CR),<br>CR with incomplete marrow recovery (CRi), partial<br>response/remission (PR), nodular PR, or PR with<br>lymphocytosis, according to the International Workshop on<br>Chronic Lymphocytic Leukemia (IWCLL) Response Criteria,<br>with modification for treatment-related lymphocytosis