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

Phase 1TerminatedNCT03876028

Novartis Pharmaceuticals10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B-cell Lymphoma

Interventions

TisagenlecleucelBIOLOGICAL

Infusion

IbrutinibDRUG

Oral (tablets or capsules)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Month 24 is planned study end

Time frame: 24 months

Severity of adverse events (AEs) and serious adverse events (SAEs)

Month 24 is planned study end

Time frame: 24 months

Ibrutinib dose modification following tisagenlecleucel infusion

Month 24 is planned study end

Time frame: 24 months

Secondary Outcomes

Response Rate

3-months post tisagenlecleucel infusion, assessed by local investigator according to Lugano criteria

Time frame: Month 3

Response Rate

6-month post tisagenlecleucel infusion, assessed by local investigator according to Lugano criteria

Time frame: Month 6

Overall Response Rate

Time frame: 24 months

Duration of Response

Time frame: 24 months

Progression Free Survival (PFS)

Time frame: 24 months

Overall Survival (OS)

Time frame: 24 months

Tisagenlecleucel transgene concentrations

qPCR will be used to measure tisagenlecleucel transgene concentrations in available tissue, such as peripheral blood, bone marrow, tumor/lymph node tissue, and/or CSF.

Data from ClinicalTrials.gov

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