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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:October 9, 2018
End Date:September 8, 2023
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.

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.


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.
We found this trial at
4
sites
Philadelphia, Pennsylvania 19104
Principal Investigator: Jakub Svoboda
Phone: 215-746-8902
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Chicago, Illinois 60637
Principal Investigator: Peter Riedell
Phone: 773-834-8980
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Kansas City, Kansas 66160
Principal Investigator: Joseph P McGuirk
Phone: 913-588-6029
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Wien,
Click here to add this to my saved trials