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Active, not recruiting

NCT Number: NCT04460248

Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) regimen in elderly treatment-naive patient with diffuse large B-cell lymphomas.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL)
  • Refuse to undergo systemic chemotherapy or not suitable for chemotherapy
  • Radiography detects measurable lesions defined as at least 1 clearly defined lesion/nodule with both long and short diameters longer than or equal to 1.5cm
  • Life expectancy of at least 3 months determined by researchers
  • The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
  • Research drugs have not been used before

Exclusion criteria

  • The patient has received systemic or local anti-tumor treatment, including chemotherapy, within three weeks before enrollment
  • The patient has complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
  • Neutrophils<1.5 x 10^9/L
  • Platelets<80 x 10^9/L
  • ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit
  • Creatinine is 1.5 times higher than the normal upper limit
  • Other concurrent and uncontrolled medical conditions that the researchers believe that they will affect the patient's participation in the study, including patients with psychosis or other known or suspected patients who cannot fully comply with the research protocol
  • HIV-infected patients
  • Patients with HbsAg positive are required to have negative HBV DNA before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and if the result is positive, anti-viral treatment is also required, and negative HBV DNA is required before entering the group
  • Other medical conditions determined by the researchers that may affect the study

Treatment and study plan

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Drug

Induction therapy:

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 1-21;
  • Lenalidomide, 25 mg qd, po, day 2-11;
  • Rituximab, 375 mg/m2, ivgtt, day 1.

Maintenance therapy:

Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days, for a maximum of 2 years.

Primary outcomes

  1. Complete response rate

    Time frame: At the end of Cycle 6 (each cycle is 21 days)

Secondary outcomes

  1. 2-year progression-free survival

    Time frame: 2 years after enrollment

  2. 2-year overall survival

    Time frame: 2 years after enrollment

  3. Incidence rate of adverse events

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

Other outcomes

  1. Single-cell ribonucleic acid (scRNA) sequencing

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

    scRNA sequencing in tumor tissue

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

The Efficacy and Safety of Zanubrutinib, Lenalidomide and Rituximab (ZR2) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jul 7, 2020
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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