Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460248
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Zanubrutinib, Lenalidomide and Rituximab (ZR2) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: Zanubrutinib, Lenalidomide and Rituximab (ZR2) Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)

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:

  1. Zanubrutinib, 160 mg bid, po, day 1-21;
  2. Lenalidomide, 25 mg qd, po, day 2-11;
  3. 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 Outcome Measures :
  1. Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Single-cell ribonucleic acid (scRNA) sequencing [ Time Frame: From enrollment to study completion, a maximum of 3 years. ]
    scRNA sequencing in tumor tissue



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL)
  • Reluctant to undergo systemic chemotherapy or not suitable for chemotherapy defined as ECOG>2, ADL<100 or CCI>1
  • 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-lymphoma 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):

    1. Neutrophils<1.5 x 10^9/L
    2. Platelets<80 x 10^9/L
    3. ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit
    4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460248


Contacts
Layout table for location contacts
Contact: Weili Zhao, M.D. and Ph.D +8613512112076 zhao.weili@yahoo.com

Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Weili Zhao, M.D. and Ph.D    13512112076    zhao.weili@yahoo.com   
Sponsors and Collaborators
Ruijin Hospital
Layout table for additonal information
Responsible Party: Zhao Weili, First Deputy Director of Shanghai Institute of Hematology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04460248    
Other Study ID Numbers: ZR2
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Lenalidomide
Zanubrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action