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

NCT05428670 | Unknown Phase 2 DMC

• 1 other identifier: HaigeYe
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Cell Lymphoma; Zanubrutinib; Elderly patients

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Percentage of participants with complete response is determined on the basis of investigator assessments according to 2014 Lugano criteria.

  At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

Secondary Outcomes (8)

• Overall survival

  Baseline up to data cut-off (up to approximately 3 years).

• Progression free survival

  Baseline up to data cut-off (up to approximately 3 years).

• Incidence rate of adverse events

  From enrollment to study completion, a maximum of 3 years.

• Direct medical costs

  At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

• EQ-5D scores

  At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

Other Outcomes (1)

• cfDNA sequencing

  Before treatment, at the end of Cycle 4 (each cycle is 21 days) and Cycle 6, and then every 6 months after the end of Cycle 6, a maximum of 2 years.

Study Arms (2)

Zanubrutinib+Rituximab+Lenalidomide

EXPERIMENTAL

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.

Drug: Zanubrutinib+Rituximab+Lenalidomide

RCHOP/RCDOP

ACTIVE COMPARATOR

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.

Drug: RCHOP/RCDOP

Interventions

Zanubrutinib+Rituximab+Lenalidomide DRUG

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

Zanubrutinib+Rituximab+Lenalidomide

RCHOP/RCDOP DRUG

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

RCHOP/RCDOP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Haige Ye, Ph.D

CONTACT

+8615967413188; haigeye@wzhospital.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 23, 2022
• Study Start: June 15, 2022
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)