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

NCT06594432 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06594432 on ClinicalTrials.gov