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Clinical Trial 19719

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03876028

Phase: Phase I
Prinicipal Investigator:

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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

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.

Objective

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

Treatments

Therapies

Medications

748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib); Tisagenlecleucel ()

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.

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