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Clinical Trial 19719

Cancer Type: Malignant Hematology
Interventions:748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib); Tisagenlecleucel

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Julio Chavez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase Ib, Multicenter Study To Determine The Safety And Tolerability of Tisagenlecleucel in Combination with Ibrutinib in Adult Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma

Summary

Objective

The primary objective of this study is to assess the safety and tolerability of tisagenlecleucel in combination with ibrutinib

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

  • Participants 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.
  • Participants 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.
  • Other eligibility criteria may apply.