Diffuse Large B-Cell Lymphoma (PORTIA)

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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.

Overview

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
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

Study Goal

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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

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

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Definitions:
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

4/19 M-GON-1210820