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Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB 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: NCT04835870
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-GCB/ABC Diffuse Large B-Cell Lymphoma Drug: Zanubrutinib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: BTK inhibitors

Drug: Rituximab
Rituximab-375 mg/m2 i.v d0 (/21d)
Other Name: MabThera

Drug: Cyclophosphamide
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
Other Name: CTX

Drug: Doxorubicin
Doxorubicin-50 mg/m2 i.v d1 (/21d)
Other Name: ADM

Drug: Vincristine
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
Other Name: VCR

Drug: Prednisone
Prednisone-100 mg p.o d1-d5 (/21d)
Other Name: Prednisonum


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Complete Response Rate [ Time Frame: up to 18 months ]
    Number of patients who achieved complete response after treatment by ZR-CHOP

  3. 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.

  4. Overall Survival [ Time Frame: up to 18 months ]
    OS will be assessed from the first ZR-CHOP given to death or last follow-up.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT04835870


Contacts
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Contact: Caixia Li, M.D +86 512 67781856 licaixia@suda.edu.cn
Contact: Jia Chen, M.D +86 512 67781856 chenjiasuzhou@gmail.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Caixia Li         
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Study Chair: Depei Wu, M.D The First Affiliated Hospital of Soochow University
More Information
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT04835870    
Other Study ID Numbers: ZR-CHOP
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: March 2021

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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
Keywords provided by The First Affiliated Hospital of Soochow University:
Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
 Zanubrutinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors