The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.

Wenzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: RCHOP/RCDOP; Drug: Zanubrutinib+Rituximab+Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT05428670

HaigeYe

Details and patient eligibility

About

This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.

Full description

In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions between the RCHOP/RCDOP chemotherapy and the ZR2 regimen. In addition, immune function tests will be performed before treatment and every 2 courses after treatment, including peripheral blood lymphocyte-monocyte ratio, cytokines, immunoglobulins, T and B cells and their quantitative analysis. Patients with ZR2 regimen will undergo gene second-generation sequencing before treatment to compare the gene mutation differences between complete response (CR) and ≤ partial response (PR) in the efficacy of ZR2 regimen, in order to find biomarkers with better efficacy in ZR2 treatment. Moreover, investigators intend to conduct pharmacokinetics/pharmacodynamics (PK/PD) correlation analysis of ZR2 regimen and pharmacoeconomic evaluation of the two regimens.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed DLBCL
• Without treatment
• ≥ 65 years old
• Measurable lesions on CT or PET-CT before treatment
• Life expectancy of at least 3 months
• Voluntary participation with the consent of the patient
• Heart, kidney, liver and other organ function evaluation were basically normal before treatment

Exclusion criteria

• Patients who previously received chemotherapy

• Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases

• Laboratory indicators before enrollment (unless caused by lymphoma):

  • Neutrophils < 1.5 × 10^9/L
  • Platelets < 80 × 10^9/L
  • Alanine aminotransferase or aspartate aminotransferase > 2 × ULN
  • Alkaline phosphatase or bilirubin > 1.5 × ULN
  • Creatinine > 1.5 × ULN

• Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation

• HIV infection

• If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled

• Other uncontrolled medical conditions that may interfere with the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Zanubrutinib+Rituximab+Lenalidomide

Experimental group

Description:

The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Zanubrutinib, 160 mg bid, po, day 2-21; Lenalidomide, 10-20 mg qd, po, day 2-14; Rituximab, 375 mg/m², ivgtt, day 1. Maintenance therapy: Patients who receive complete response or partial response after induction therapy will receive lenalidomide 10-20 mg qd po during 1-21 days in every 28 days, for a maximum of 2 years.

Treatment:

Drug: Zanubrutinib+Rituximab+Lenalidomide

RCHOP/RCDOP

Active Comparator group

Description:

The RCHOP/RCDOP regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Rituximab, 375 mg/m², ivgtt, day 1; Cyclophosphamide, 500-750 mg/m², ivgtt, day 2; Doxorubicin, 50 mg/m², ivgtt day 2 (liposomal doxorubicin, 20-30 mg/m², ivgtt day 2 or Epirubicin, 50-60 mg/m², ivgtt day 2); Vincristine, 1.4 mg/m², iv day 2 or vindesine, 3mg/m², iv day 2; Prednisone, 100 mg qd, po day 2-6.

Treatment:

Drug: RCHOP/RCDOP