Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06570447
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B-Cell Lymphoma-Recurrent
  • Diffuse Large B-Cell Lymphoma-Refractory

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    For Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.
  • Chidamide — DRUG
    Chidamide: 30 mg/d orally twice a week for 21 days as a treatment cycle.

Study Details

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Key Dates

Start date
May 15, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: combination therapy of Glofitamab, chidamide
    Each subject will be given combination therapy of Glofitamab, chidamide. Glofitamab Injection with 2.5 mg on D8 and 10 mg on D15 in Cycle 1; with 30mg in Cycle 2-12, every 3 weeks.

Primary Outcome Measure

complete response rate (CR) [ Time Frame: up to the end of 12 cycles of treatment (each cycle is 28 days) ]

Central Contacts

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