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

NCT04835870 | Unknown Phase 2

• 1 other identifier: ZR-CHOP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 16

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

Conditions

Non-GCB/ABC Diffuse Large B-Cell Lymphoma

Keywords

Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival(PFS)

  To measure the duration of response to ZR-CHOP over a follow-up period of 18 months

  up to 18 months

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  up to 18 months

• Complete Response Rate

  up to 18 months

• Duration of Response

  up to 18 months

• Overall Survival

  up to 18 months

• Adverse events profile

  Measured from start of treatment until 28 days after last dose

Study Arms (1)

R-CHOP + Zanubrutinib

EXPERIMENTAL

Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Zanubrutinib DRUG

Zanubrutinib-160mg bid PO d0-d20(1-21d)

Also known as: BTK inhibitors

R-CHOP + Zanubrutinib

Rituximab DRUG

Rituximab-375 mg/m2 i.v d0 (/21d)

Also known as: MabThera

R-CHOP + Zanubrutinib

Cyclophosphamide DRUG

Cyclophosphamide-750 mg/m2 i.v d1 (/21d)

Also known as: CTX

R-CHOP + Zanubrutinib

Doxorubicin DRUG

Doxorubicin-50 mg/m2 i.v d1 (/21d)

Also known as: ADM

R-CHOP + Zanubrutinib

Vincristine DRUG

Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)

Also known as: VCR

R-CHOP + Zanubrutinib

Prednisone DRUG

Prednisone-100 mg p.o d1-d5 (/21d)

Also known as: Prednisonum

R-CHOP + Zanubrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Non-GCB DLBCL with extrinsic involvement
• Age ≥ 18 years
• Measurable disease of at least 15mm(node)/10mm（extranodal）
• ECOG performance status 0-2
• 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
• Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L)
• Estimated survival time ≥3 months
• 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

You may not qualify if:

• Accepted major surgery within 4 weeks before treatment;
• Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
• Previous history of indolent lymphoma;
• 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;
• History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
• Requires treatment with a strong/medium CYP3A inducer;
• The previous use of anthracycline-based drugs \> 150 mg/m2;
• 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;
• HIV infection and/or active hepatitis B or active hepatitis C;
• Uncontrolled systemic infection;
• Pregnant or breasting-feeding women;
• According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (16)

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

Nantong Tumor Hospital

Nantong, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Suzhou Hongci Hematology Hospital

Suzhou, Jiangsu, China

RECRUITING

Zhangjiagang First Peoples Hospital

Suzhou, Jiangsu, China

RECRUITING

Affiliated Hospital Of Jiangnan University

Wuxi, Jiangsu, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Related Publications (1)

• Geng H, Jia S, Zhang Y, Li J, Yang Q, Zeng L, Zong X, Lu Y, Lu S, Zhou J, Li C, Wu D. Efficacy and safety of zanubrutinib plus R-CHOP in treatment of non-GCB DLBCL with extranodal involvement. Front Immunol. 2023 Aug 21;14:1219167. doi: 10.3389/fimmu.2023.1219167. eCollection 2023.

  PMID: 37671152 DERIVED

MeSH Terms

Interventions

zanubrutinib; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Depei Wu, M.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Jia Chen, M.D

CONTACT

+86 512 67781856; chenjiasuzhou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 16, 2022

Record last verified: 2022-03

Locations

CN (16)