Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies (NCT01871675) | Clinical Trial Compass
CompletedPhase 1
Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies
United States48 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Dose Escalation Phase
✓. Dose Expansion Phase
✓. Disease status requirement:
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤2.
✓. Subject must have measurable disease using the disease-specific response criteria for NHL or CLL
✓. Age ≥ 18 years.
✓. Subject has recovered from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions.
✓. Adequate organ system function ≤2 weeks prior to Day 1, defined as follows:
✕. Prior autologous transplant or radioimmunotherapy ≤6 months prior to the first dose of trial treatment.
✕. Subject has a high grade lymphoma such as Burkitt's, lymphoblastic or small non-cleaved cell lymphomas. Subjects with intermediate grade lymphoma (such as diffuse large B-cell lymphoma) are eligible.
✕. Subjects with diffuse B-cell lymphoma must either not be eligible for autologous bone marrow transplant (BMT) or relapsed after autologous BMT.
What they're measuring
1
The number of adverse events, serious adverse events, and dose limiting toxicities as a measure of safety and tolerability
. More than three previous cytotoxic chemotherapy regimens for subjects treated on the arm containing bendamustine.
✕. Subjects who have had a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies.
✕. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), radiation therapy (other than whole brain irradiation \[WBI\]) surgery or ablative therapy or investigational drugs/devices ≤28 days before first dose of trial treatment.
✕. Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of trial treatment.