CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07397832
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

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

Interventions

  • Chidamide — DRUG
    Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.
  • Rituximab — DRUG
    Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
  • Polatuzumab Vedotin — DRUG
    Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
  • Chidamide Maintenance — DRUG
    For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.

Study Details

A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma

Key Dates

Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
Jul 30, 2028
Completion
Dec 30, 2028

Study Design

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

Arms

  • Experimental: Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten
    Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days ]

Central Contacts

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