Actively Recruiting

Phase 2
Age: 70Years - 100Years
All Genders
ID06758037

HiR+X Therapy for Newly Diagnosed Elderly Patients with Diffuse Large B-Cell Lymphoma Intolerant to Chemotherapy Guided by Molecular Subtyping

Led by First Affiliated Hospital of Ningbo University · Updated on 2025-03-18

50

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of HiR (Zebtorizumab, Lenalidomide) combined with a targeted drug (X) guided by next-generation sequencing (NGS) molecular typing to assess therapeutic effects and safety in newly diagnosed elderly patients aged 70 years and older with diffuse large B-cell lymphoma (DLBCL) who are unfit or frail and intolerant to chemotherapy. The study also aims to identify genetic subtypes that may benefit from this HiR-X therapy. All participants will first receive one cycle of HiR induction therapy. On enrollment day, tissue and blood samples will be collected for NGS testing. Then, over six additional cycles, the targeted drug X will be selected based on the molecular typing results. Dosing includes Zebtorizumab 375mg/m² on day 1 and Lenalidomide 10-25mg on days 1-10 per cycle. The X drug varies by subtype: Ocalivumab for MCD/BN2/TP53 types, Chidamide for EZB type, and PD-1 monoclonal antibody for EBV-positive N1-like and nonspecific types. Participants will be monitored throughout the six 21-day cycles, with assessments focused on the complete response rate after treatment completion. Safety evaluations, tissue and blood molecular testing, and clinical observations will guide therapy adjustments. The study is planned to continue until June 2027, and participants will be followed to assess therapy response and monitor overall health and treatment tolerability.

CONDITIONS

Brief Title

Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • ECOG performance status score of 0 to 3
  • Classified as unfit or frail by simplified geriatric assessment
  • Histologically confirmed CD20-positive diffuse large B-cell lymphoma, excluding transformed type 2 DLBCL
  • Newly diagnosed and previously untreated
  • Cardiac, liver, and kidney function within specified limits (creatinine less than 2 times ULN; ALT/AST less than 2.5 times ULN; total bilirubin less than 2 times ULN)
  • At least one measurable lymphoma lesion
  • Intolerant to or unwilling to receive standard CHOP chemotherapy
  • Able to understand and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Central nervous system involvement at disease onset
  • Known HIV infection
  • Pregnant or breastfeeding women
  • Other tumors requiring treatment
  • Uncontrolled active infection
  • Active hepatitis with HBV-DNA above 2000/mL despite antiviral treatment
  • Unable to understand or comply with study protocol or provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Each cycle lasts 21 days, with a total of 6 cycles.

Participants receive one cycle of HiR induction therapy followed by six cycles of HiR combined with an additional drug determined by molecular subtyping.

7 treatment cycles with dosing schedules based on molecular typing

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 3150101

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial.

Irina V Poddubnaya, Sergey M Alekseev, Kamil D Kaplanov...

https://pubmed.ncbi.nlm.nih.gov/31724191