Status:
TERMINATED
Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Other eligibility criteria may apply.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03876028
Start Date
June 11 2019
End Date
November 1 2021
Last Update
January 31 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104