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

  • STATUS
    Recruiting
  • End date
    Nov 15, 2023
  • participants needed
    32
  • sponsor
    Novartis Pharmaceuticals
Updated on 21 March 2021
measurable disease
anthracyclines
b-cell lymphoma

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.

Details
Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment Pembrolizumab, Tisagenlecleucel
Clinical Study IdentifierNCT03630159
SponsorNovartis Pharmaceuticals
Last Modified on21 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Diffuse Large B-Cell Lymphoma?
Do you have any of these conditions: Diffuse Large B-Cell Lymphoma or diffuse large cell lymphoma or diffuse large b cell lymphoma?
Do you have any of these conditions: diffuse large cell lymphoma or diffuse large b cell lymphoma or Diffuse Large B-Cell Lymphoma?
Do you have any of these conditions: diffuse large cell lymphoma or Diffuse Large B-Cell Lymphoma or diffuse large b cell lymphoma?
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
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