Clinical trial · Interventional
Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Tisagenlecleucel | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ibrutinib (before leukapheresis) + Tisagenlecleucel
- description
- Patients will start ibrutinib treatment before leukapheresis
- interventionNames
- Biological: Tisagenlecleucel
- Drug: Ibrutinib
- type
- EXPERIMENTAL
- label
- Ibrutinib (after leukapheresis) + Tisagenlecleucel
- description
- Patients will start ibrutinib treatment after leukapheresis.
- interventionNames
- Biological: Tisagenlecleucel
- Drug: Ibrutinib
Primary outcomes (3)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChavez JC, Napier E, Bondanza A, Lewandowski A, Mataraza J, Quinn D, Kwon P, Locke FL, Engels B, Awasthi R, Georgala P, Leyk M, Hynds D, Moschetta M, Schuster SJ. Tisagenlecleucel in combination with ibrutinib in adults with relapsed and/or refractory large B-cell lymphomas. Blood Neoplasia. 2025 Oct 24;3(1):100176. doi: 10.1016/j.bneo.2025.100176. eCollection 2026 Feb. PMID 41536778