Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL

Sponsor
Affiliated Hospital of Nantong University
Study ID
NCT06530511
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab vedotin — DRUG
    Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
  • Rituximab — DRUG
    Rituximab: 375 mg/m2, IV Drip infusion, D1
  • Orelabrutinib — DRUG
    Orelabrutinib: 150 mg/time, qd, po, D1-21

Study Details

This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2024
Primary completion
Feb 1, 2026
Completion
Aug 1, 2026

Study Design

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

Arms

  • Experimental: PRO
    The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles. The dose and administration method of the study drug were as follows: * Polatuzumab: 1.8 mg/kg, IV, D1; * Rituximab: 375 mg/m2, IV, D1; * Orelabrutinib: 150 mg/time, qd, po, D1-21;

Primary Outcome Measure

CRR [ Time Frame: 6 months ]

Central Contacts

Related Studies