Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05600660

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

Primary Central Nervous System Lymphoma Clinical Trial

Official title:
Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study

Clinical Trial Summary

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.

Clinical Trial Description

This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of Orelabrutinib, rituximab and methotrexate as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 28 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by Orelabrutinib maintenance chemotherapy up to one year. After 6 cycles of induction chemotherapy, autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be performed for transplantation eligible patients . Follow-ups should be taken up to the first 2 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events. ;

Study Design

Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma
Clinical Trial Details
NCT number NCT05600660
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian, prof.
Phone +8613605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 2
Start date August 1, 2022
Completion date December 31, 2027
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
Not yet recruiting NCT04066920 - IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL 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