Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05036577

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL — ORMD2021  

Primary Central Nervous System Lymphoma Clinical Trial

Official title:
A Dose-escalating Pilot Study of Orelabrutinib in Combination With Rituximab, Methotrexate and Dexamethasone for Newly-diagnosed Primary Central Nervous System Lymphoma

Clinical Trial Summary

This is a single arm, single center, open label pilot study of Orelabrutinib combined with Rituximab, high-dose (HD) Methotrexate and Dexamethasone in newly-diagnosed primary central nervous system lymphpoma (PCNSL). The purpose is to evaluate the safety and to find the optimal dose of Orelabrutinib and Methotrexate in this combination treatment for newly-diagnosed PCNSL patients.

Clinical Trial Description

The eligible patients will be treated with Orelabrutinib combined with Rituximab, high-dose Methotrexate and Dexamethasone during induction treatment (6-8 cycles; 21 days/cycle): Rituximab 375 mg/m2, intravenous infusion, d1; HD-MTX 3.5 g/m2 intravenous infusion (3h), d2; Dexamethasone 10-15 mg, iv, d1-4. Orelabrutinib will be given 72h after MTX infusion or until MTX clearance. The study will investigate optimal dose combination of Orelabrutinib and MTX implementing BOIN waterfall design. The starting dose of Orelabrutinib is 150 mg/d and the dose will be escalated to 200 mg/d, throughout the whole cycle. Meanwhile, the starting dose of MTX is 3g/m2 and will be escalated to 5g/m2, throughout induction phase. Dose escalation and movement in dose matrix will be determined by BOIN algorithm. For CR/CRu patients after completion of induction treatment, daily Orelabrutinib will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first). Patients will be evaluated every 2 cycles during induction therapy and every 12 weeks during maintenance therapy. ;

Study Design

Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma
Clinical Trial Details
NCT number NCT05036577
Study type Interventional
Source Huashan Hospital
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 10, 2021
Completion date September 30, 2024
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 NCT02836158 - Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL Phase 2/Phase 3
Recruiting NCT02657785 - Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy 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
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
Recruiting NCT04899427 - Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma Phase 2