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Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients (PORTIA)

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ClinicalTrials.gov Identifier: NCT03630159
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Biological: Tisagenlecleucel Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (Open label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : September 8, 2023


Arm Intervention/treatment
Experimental: Tisagenlecleucel+Pembrolizumab Biological: Tisagenlecleucel
Gene modified autologous T cells
Other Name: CTL019

Drug: Pembrolizumab
anti PD-1




Primary Outcome Measures :
  1. Percent of participants recieving pembrolizumab per protocol schedule [ Time Frame: 21 days after first pembrolizumab infusion ]
  2. Dose Timing part: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 21 days after first pembrolizumab infusion ]
  3. Expansion part: Overall response rate (ORR) [ Time Frame: 3 month post tisagenlecleucel infusion ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: 24 months ]
  2. Progression Free Survival (PFS) [ Time Frame: 24 months ]
  3. Overall Survival (OS) [ Time Frame: 24 months ]
  4. In vivo cellular kinetics of tisagenlecleucel in blood, bone marrow, lymph nodes and other tissues by qPCR and flow cytometry [ Time Frame: 24 months ]
  5. Impact of pembrolizumab dosing strategy on the cellular kinetics of tisagenlecleucel by qPCR and flow cytometry [ Time Frame: 24 months ]
  6. Immunogenicity measured by antibody titres specific to tisagenlecleucel molecule and by the presence of T lymphocytes activated by the tisagenlecleucel protein [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed DLBCL per local histopathology assessment.
  • Relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being not candidates for or not consenting to ASCT.
  • Measurable disease at time of enrollment
  • ECOG performance status that is either 0 or 1 at screening.

Exclusion Criteria:

  • Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of CNS.
  • Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy.
  • Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was >4 weeks before enrollment.
  • Prior allogeneic HSCT.
  • Unstable angina and/or myocardial infarction and/or coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease
  • Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, other immune checkpoint inhibitors.
  • History of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630159


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Georgia
Emory University School of Medicine SC CTL019 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tolu Adewuya    404-778-3708    tolu.adewuya@emory.edu   
Principal Investigator: Edmund K. Waller         
United States, Illinois
University of Chicago Medical Center, Hematology & Oncology Recruiting
Chicago, Illinois, United States, 60637
Contact: Peyton Patrick    773-834-8980    ppatrick@medicine.bsd.uchicago.edu   
Principal Investigator: Peter Riedell         
United States, Kansas
University of Kansas Hospital and Medical Center U of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Nichola Fell    913-588-6029    nfell@kumc.edu   
Principal Investigator: Joseph P McGuirk         
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tanya Latorre    215-746-8902    tanya.Latorre@uphs.upenn.edu   
Principal Investigator: Jakub Svoboda         
Austria
Novartis Investigative Site Recruiting
Wien, Austria, 1090
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H1T 2M4
Germany
Novartis Investigative Site Recruiting
Koeln, Germany, 50937
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03630159     History of Changes
Other Study ID Numbers: CCTL019J2101
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Lymphoma tisagenlecleucel
Diffuse Large B-cell Lymphoma
CTL019
PORTIA
DLBCL
tisagenlecleucel
pembrolizumab
r/r Diffuse large B-cell Lymphoma
relapsed/refractory Diffuse large B-cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents