Diffuse Large B-Cell Lymphoma (PORTIA)
Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
|This study is recruiting: Phase Ib||Actual Start Date: [October 9, 2018]||
Estimated Completion Date [July 15, 2023]
|Novartis Reference Number: CCTL019J2101|
|Condition: Diffuse Large B-Cell Lymphoma
||Interventions: tisagenlecleucel, pembrolizumab||Estimated Enrollment: [32 participants]||ClinicalTrials.gov Identifier: NCT03630159|
|This study is recruiting: Phase Ib||Actual Start Date: [October 9, 2018]|
|Estimated Completion Date: [September 8, 2023]||Novartis Reference Number: CCTL019J2101|
|Condition: Diffuse Large B-Cell Lymphoma (DLBCL)||Interventions: tisagenlecleucel, pembrolizumab|
|Estimated Enrollment: [32 participants]||ClinicalTrials.gov Identifier: NCT03630159|
A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.
Participants may be eligible to participate if they:
- Are ≥ 18 years of age
- Have confirmed relapsed or refractory DLBCL, and
- Received ≥ 2 lines of systemic therapy, including anti-CD20 and anthracycline-based chemotherapy
- Progressed after or not eligible for autologous stem cell transplant
- Meet other eligibility criteria
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ASCT - autologous stem cell transplant, CD20 - Cluster of differentiation 20, DLBCL - Diffuse Large B-Cell Lymphoma, r/r - Relapsed/Refractory
Last Updated: May 1, 2019