NCT06594432

Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement

A Study on the Efficacy and Safety of Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the Efficacy Indicators of CSF-ctDNA.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	R-CHOP+Z+MTX	After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and MCD, BN2, and N1 subtypes will receive 5 cycles of R-CHOP combined with MTX + Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib. After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative. Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles.
DRUG	R-CHOP+MTX	After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA (+) and EZB, A53, and other gene subtypes will receive 5 cycles of R-CHOP combined with MTX, followed by 1 cycle of R-MTX. After completing the above induction therapy, Patients with negative CSF-ctDNA results will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA results, the investigator will decide to continue treatment with Rituximab one more cycle combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns negative. Each combined regimen consists of a 21-day treatment cycle, and efficacy will be evaluated every three treatment cycles.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China