CHiR Therapy for Elderly DLBCL Intolerant to Chemo

Sponsor
First Affiliated Hospital of Ningbo University
Study ID
NCT06764017
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • CHiR-DEL — DRUG
    Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.

Study Details

The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.

Key Dates

First listed
Jan 8, 2025
Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CHiR
    The combined regimen of chidamide, zanubrutinib, and lenalidomide (CHiR) is employed to treat elderly patients with double-expressor lymphoma. This study aims to explore the efficacy and safety of this regimen in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.

Primary Outcome Measure

the complete remission rate (CRR) [ Time Frame: Each cycle consists of 21 days, with a total of 8 cycles. ]

Central Contacts

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