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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Diffuse Large B Cell Lymphoma (DLBCL)
Interventions
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."

Trial Locations (1)

210029

Hematological Department, People's Hospital of Jiangsu Province, Nanjing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER

NCT06594432 - Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement | Biotech Hunter | Biotech Hunter