Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Biological: Tisagenlecleucel
  • Drug: Ibrutinib

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. Confirmed DLBCL as per the local histopathological assessment.

   2. 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.

   3. Measurable disease at time of enrollment.

   4. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at
   screening.

   5. Adequate renal, liver, and bone marrow, organ function, and minimum level of pulmonary
   reserve.

Exclusion Criteria:

   1. Patients with Richter's transformation, Burkitt's lymphoma, and primary DLBCL of the
   CNS.

   2. Prior anti-CD19 directed therapy.

   3. Prior gene therapy.

   4. Prior adoptive T cell therapy.

   5. Prior ibrutinib therapy within the 30 days prior to screening.

   6. 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.

   7. Prior allogeneic HSCT

   8. . 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias
6507234247
Recruiting