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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Biological: Tisagenlecleucel; Drug: Ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03876028

CCTL019L12101C

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Ibrutinib (before leukapheresis) + Tisagenlecleucel

Experimental group

Description:

Patients will start ibrutinib treatment before leukapheresis

Treatment:

Biological: Tisagenlecleucel

Drug: Ibrutinib

Ibrutinib (after leukapheresis) + Tisagenlecleucel

Experimental group

Description:

Patients will start ibrutinib treatment after leukapheresis.

Treatment:

Biological: Tisagenlecleucel

Drug: Ibrutinib