NCT01871675

Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies

An Open-label, Phase Ib Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Select Subjects With Lymphoma or Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.

Detailed description

This trial consists of two parallel arms. For each treatment arm, a 3+3 dose escalation design will be applied in 3-6 subject cohorts until the maximum tolerated dose of IPI-145 when given with rituximab (Arm 1) or in combination with rituximab and bendamustine (Arm 2) is determined. Treatment arm selection will be chosen by the investigator and will depend on the agents previously administered to the subject. Once the MTD has been determined, the arms will move on to a dose expansion phase. During the dose expansion phase, each treatment arm will enroll to population specific cohorts to assess efficacy. All subjects must have had at least one prior anticancer treatment. The dose expansion cohorts are: Arm 1: Cohort A - CLL: Cohort B - CD20+ NHL Arm 2: Cohort A - CLL: Cohort B - CD20+ NHL

Conditions

• Lymphoma
• Chronic Lymphocytic Leukemia
• Non-Hodgkin Lymphoma
• T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	IPI-145
DRUG	Rituximab
DRUG	Bendamustine

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-06-07
• Last updated: 2016-07-11

Locations

4 sites across 1 country: United States