Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04066920

IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL

Primary Central Nervous System Lymphoma Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

Given the limited activity of salvage therapy with high-dose methotrexate re-treatment and/or alkylator-based treatment in patients with relapse or refractory PCNSL, the development of novel salvage chemotherapy regimen remains an area of clinical unmet need.

Ibrutinib, an oral inhibitor of bruton tyrosine kinase (BTK), is known to induce death of diffuse large B-cell lymphoma (DLBCL) cells with dysregulated B-cell receptor (BCR) signaling and has shown promising activity in patients with a variety of B-cell malignancies. Recently, several studies reported that ibrutinib may have an excellent single-agent clinical activity against relapsed or refractory PCNSL. Furthermore, proven pharmacokinetic data suggested that ibrutinib successfully penetrated the BBB and reached the achievable concentration in cerebrospinal fluid. When ibrutinib is administered in combination with BBB-destructing chemotherapeutic agents (such as, temozolomide or etoposide) for salvage treatment of PCNSL, therefore, anti-lymphoma activity of ibrutinib could be maximized.

In this context, this phase II study is designed to evaluate the efficacy and safety of IBER salvage chemotherapy followed by ibrutinib maintenance for transplant ineligible patients with relapsed or refractory PCNSL. ;

Study Design

Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma
Clinical Trial Details
NCT number NCT04066920
Study type Interventional
Source Chonnam National University Hospital
Contact Deok-Hwan Yang, M.D., Ph.D.
Phone +82-61-379-7636
Email drydh1685@hotmail.com
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2019
Completion date September 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04083066 - Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma Phase 4
Active, not recruiting NCT02313389 - Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma Phase 3
Recruiting NCT02657785 - Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy Phase 2/Phase 3
Recruiting NCT02836158 - Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL Phase 2/Phase 3
Recruiting NCT06445257 - A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL N/A
Recruiting NCT05135858 - Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma Phase 1
Completed NCT01421524 - Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma Phase 1
Active, not recruiting NCT00863460 - Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients Phase 2
Active, not recruiting NCT05036577 - A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL Phase 1
Recruiting NCT04514393 - Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma Phase 2
Recruiting NCT03733327 - BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT Phase 2/Phase 3
Recruiting NCT00455286 - a Phase II Study in Primary Central Nervous System Lymphoma Phase 2
Completed NCT02301364 - Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) Phase 2
Completed NCT00112593 - Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer N/A
Completed NCT02669511 - PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma Phase 2
Not yet recruiting NCT04457869 - A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL) Phase 2
Recruiting NCT02655744 - Prospective Neurobehavioral Outcomes Follow-up in Primary CNS Lymphoma Patients Treated With Cranial Radiotherapy Combined With or Without MTX-based Chemotherapy According to the Multidisciplinary Treatment Guidelines Implemented at a Single Institute
Recruiting NCT02399189 - MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma Phase 2
Recruiting NCT04831658 - A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma Phase 1/Phase 2
Recruiting NCT04899427 - Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma Phase 2