Study to assess the safety of the study drug IPI-145 or ofatumumab in leukemia patients

Phase 1

• Conditions: Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma; MedDRA version: 18.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003639-31-FR
• Lead Sponsor: Infinity Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 307

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

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 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified