Spots Global Cancer Trial Database for Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies

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Trial Identification

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

Official Title: 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

Study ID: NCT01871675

Conditions

Lymphoma

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

T-cell Lymphoma

Interventions

IPI-145

Rituximab

Bendamustine

Study Description

Brief 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