A Phase II Study of Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

Sponsor
Sun Yat-sen University
Study ID
NCT05527912
Phase
PHASE2
Status
Unknown

Conditions

  • Double Express Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy — DRUG
    All subjects received two courses of the following treatment: Rituximab ，375mg/m²， D1； Chidamiade ，20mg ，biw， d1-14； Zanubrutinib ，160mg， bid， d1-21； three weeks for a period of treatment, all subjects complete tumor assessment after two courses of treatment, patients which achieve complete remission continue for up to 8 sessions, patients achieve partial response and stable disease combined use of the following CHOP threapy to 6 courses, Patients with progressive disease dropped out of this research. CHOP Therapy: Cyclophosphamide， 750mg/m² ，D1； Vincristine， 1.4mg/m² ，D1 (maximum：2mg)； Doxorubicin or pirarubicin， 50mg/m²， D1； Prednisone ，30mg ，tid， D1-5.

Study Details

This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL.

Key Dates

Start date
Feb 24, 2023
Status verified
Apr 2023
Primary completion
Sep 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (RCZ WITH CHOP)
    Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

Primary Outcome Measure

EOT-CRR [ Time Frame: 12 months ]

Central Contacts