Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

September 14, 2022 updated by: The First Affiliated Hospital of Soochow University

Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of USTC Anhui Provincial Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China
        • Recruiting
        • The first affiliated hospital of xiamen university
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nantong, Jiangsu, China
        • Recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, China
        • Recruiting
        • Changshu No.1 People's Hospital
        • Contact:
      • Suzhou, Jiangsu, China
        • Recruiting
        • Suzhou Hongci Hematology Hospital
        • Contact:
        • Contact:
      • Suzhou, Jiangsu, China
        • Recruiting
        • Zhangjiagang First Peoples Hospital
        • Contact:
      • Wuxi, Jiangsu, China
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
      • Wuxi, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed Non-GCB DLBCL with extrinsic involvement
  2. Age ≥ 18 years
  3. Measurable disease of at least 15mm(node)/10mm（extranodal）
  4. ECOG performance status 0-2
  5. Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN
  6. Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)
  7. Estimated survival time ≥3 months
  8. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study

Exclusion Criteria:

  1. Accepted major surgery within 4 weeks before treatment;
  2. Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
  3. Previous history of indolent lymphoma;
  4. Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
  5. History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
  6. Requires treatment with a strong/medium CYP3A inducer;
  7. The previous use of anthracycline-based drugs > 150 mg/m2;
  8. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
  9. HIV infection and/or active hepatitis B or active hepatitis C;
  10. Uncontrolled systemic infection;
  11. Pregnant or breasting-feeding women;
  12. According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-CHOP + Zanubrutinib
Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Drug: Zanubrutinib
Zanubrutinib-160mg bid PO d0-d20(1-21d)
Other Names:
  • BTK inhibitors
Drug: Rituximab
Rituximab-375 mg/m2 i.v d0 (/21d)
Other Names:
  • MabThera
Drug: Cyclophosphamide
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
Other Names:
  • CTX
Drug: Doxorubicin
Doxorubicin-50 mg/m2 i.v d1 (/21d)
Other Names:
  • ADM
Drug: Vincristine
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
Other Names:
  • VCR
Drug: Prednisone
Prednisone-100 mg p.o d1-d5 (/21d)
Other Names:
  • Prednisonum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival(PFS)
Time Frame: up to 18 months
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: up to 18 months
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
up to 18 months
Complete Response Rate
Time Frame: up to 18 months
Number of patients who achieved complete response after treatment by ZR-CHOP
up to 18 months
Duration of Response
Time Frame: up to 18 months
Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up.
up to 18 months
Overall Survival
Time Frame: up to 18 months
OS will be assessed from the first ZR-CHOP given to death or last follow-up.
up to 18 months
Adverse events profile
Time Frame: Measured from start of treatment until 28 days after last dose
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
Measured from start of treatment until 28 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZR-CHOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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