Clinical trial · Interventional
IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL
Clinical Efficacy and Safety of IBER Salvage Treatment Followed by Ibrutinib Maintenance for Transplant-ineligible Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL): a Multicenter, Single-arm, Prospective Phase II Study
NCT04066920CI-TRIAL-00040225unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single-arm, prospective phase II study to evaluate the efficacy and safety of a novel combination regimen for relapsed/refractory PCNSL. Specifically, ibrutinib will be administered in combination with ifosfamide, etoposide and rituximab (IBER) as a salvage chemotherapy, which is followed by maintenance ibrutinib monotherapy of fixed duration.
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 |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBER salvage chemotherapy followed by ibrutinib maintenance therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBER treatment arm
- description
- This is the only arm in a single-arm phase II study.
- interventionNames
- Drug: IBER salvage chemotherapy followed by ibrutinib maintenance therapy
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- From date of starting the study treatment until the date of finishing the study treatment for any reason, assessed up to 10 months
- description
- The percentage of patients with a complete response (CR) or a partial response (PR)
Secondary outcomes (1)
- measure
- Safety and tolerability of the study treatment
- timeFrame
- From the first day of the first cycle of IBER induction chemotherapy to 30 days after the last dose of study drug, assessed up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed PCNSL of CD20+ diffuse large B cell lymphoma (DLBCL) * PCNSL relapsed or refractory after frontline methotrexate-based chemotherapy (with or without radiation therapy) * At least one measurable lesion, which is defined as longest diameter of lesion \> 0.5 cm, by contrast-enhanced MRI * ECOG performance status 0-2 * Normal function of major organs Exclusion Criteria: * PCNSL other than DLBCL * Primary ocular lymphoma * PCNSL accompanied by systemic involvement * Active infection with hepatitis B or C virus * Known history of human immunodeficiency virus (HIV) infection * Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
References
Publications (16)
- BACKGROUNDVillano JL, Koshy M, Shaikh H, Dolecek TA, McCarthy BJ. Age, gender, and racial differences in incidence and survival in primary CNS lymphoma. Br J Cancer. 2011 Oct 25;105(9):1414-8. doi: 10.1038/bjc.2011.357. Epub 2011 Sep 13. PMID 21915121
- BACKGROUNDFerreri AJ, Abrey LE, Blay JY, Borisch B, Hochman J, Neuwelt EA, Yahalom J, Zucca E, Cavalli F, Armitage J, Batchelor T. Summary statement on primary central nervous system lymphomas from the Eighth International Conference on Malignant Lymphoma, Lugano, Switzerland, June 12 to 15, 2002. J Clin Oncol. 2003 Jun 15;21(12):2407-14. doi: 10.1200/JCO.2003.01.135. PMID 12805341
- BACKGROUNDReni M, Mazza E, Foppoli M, Ferreri AJ. Primary central nervous system lymphomas: salvage treatment after failure to high-dose methotrexate. Cancer Lett. 2007 Dec 18;258(2):165-70. doi: 10.1016/j.canlet.2007.10.009. Epub 2007 Nov 13. PMID 17993246
- BACKGROUNDFischer L, Thiel E, Klasen HA, Birkmann J, Jahnke K, Martus P, Korfel A. Prospective trial on topotecan salvage therapy in primary CNS lymphoma. Ann Oncol. 2006 Jul;17(7):1141-5. doi: 10.1093/annonc/mdl070. Epub 2006 Apr 7. PMID 16603598
- BACKGROUNDReni M, Zaja F, Mason W, Perry J, Mazza E, Spina M, Bordonaro R, Ilariucci F, Faedi M, Corazzelli G, Manno P, Franceschi E, Pace A, Candela M, Abbadessa A, Stelitano C, Latte G, Ferreri AJ. Temozolomide as salvage treatment in primary brain lymphomas. Br J Cancer. 2007 Mar 26;96(6):864-7. doi: 10.1038/sj.bjc.6603660. Epub 2007 Feb 27. PMID 17325700
- BACKGROUNDWilson WH, Young RM, Schmitz R, Yang Y, Pittaluga S, Wright G, Lih CJ, Williams PM, Shaffer AL, Gerecitano J, de Vos S, Goy A, Kenkre VP, Barr PM, Blum KA, Shustov A, Advani R, Fowler NH, Vose JM, Elstrom RL, Habermann TM, Barrientos JC, McGreivy J, Fardis M, Chang BY, Clow F, Munneke B, Moussa D, Beaupre DM, Staudt LM. Targeting B cell receptor signaling with ibrutinib in diffuse large B cell lymphoma. Nat Med. 2015 Aug;21(8):922-6. doi: 10.1038/nm.3884. Epub 2015 Jul 20.