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

NCT ID: NCT05428670

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed 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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zanubrutinib+Rituximab+Lenalidomide

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.

Group Type: EXPERIMENTAL

Zanubrutinib+Rituximab+Lenalidomide

Intervention Type: DRUG

Zanubrutinib is a bruton' s tyrosine kinase inhibitor independently developed in China.

RCHOP/RCDOP

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.

Group Type: ACTIVE_COMPARATOR

RCHOP/RCDOP

Intervention Type: DRUG

RCHOP/RCDOP is the classic treatment of diffuse large B cell lymphoma.

Interventions

Zanubrutinib+Rituximab+Lenalidomide

Zanubrutinib is a bruton' s tyrosine kinase inhibitor independently developed in China.

Intervention Type: DRUG

RCHOP/RCDOP

RCHOP/RCDOP is the classic treatment of diffuse large B cell lymphoma.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Haige Ye

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haige Ye, Ph.D

Role: CONTACT

haigeye@wzhospital.cn

+8615967413188

Facility Contacts

Xian Shen, Ph. D

Role: primary

wyyyclinical@126.com

+86057755578055

Other Identifiers

HaigeYe

Identifier Type: -

Identifier Source: org_study_id