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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The Colorado Blood Cancer Institute
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Oklahoma University
Oklahoma City, Oklahoma, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The number of adverse events, serious adverse events, and dose limiting toxicities as a measure of safety and tolerability
The maximum tolerated dose of IPI-145 defined as the optimal dose at which ≤1 of 6 patients experiences a DLT assessed by NCI CTCAE v4.0.
Time frame: up to 12 months
Antitumor activity
Preliminary information on antitumor activity of IPI-145 when combined with rituximab, or bendamustine/rituximab as measured by objective response rate, progression free survival and overall survival data
Time frame: Up to 5 years
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