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

Status: Active

Description

A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r / r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.

Eligibility Criteria

Inclusion Criteria

  • Confirmed DLBCL as per the local histopathological assessment.
  • Relapsed or refractory disease having received 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 ineligible for or not consenting to ASCT.
  • Measurable disease at time of enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
  • Adequate renal, liver, and bone marrow, organ function, and minimum level of pulmonary reserve.

Exclusion Criteria

  • Patients with Richter's transformation, Burkitt's lymphoma, and primary DLBCL of the CNS.
  • Prior anti-CD19 directed therapy.
  • Prior gene therapy.
  • Prior adoptive T cell therapy.
  • Prior ibrutinib therapy within the 30 days prior to screening.
  • 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
  • . Significant cardiac abnormality including history of myocardial infarction within 6 months prior to screening as detailed in the study protocol.

Locations & Contacts

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: In review
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CCTL019L12101C
Secondary IDs NCI-2019-03798
Clinicaltrials.gov ID NCT03876028