- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290090
ZR2 Followed by Immunochemotherapy in Elderly Patients With Newly-diagnosed DLBCL
Prospective, Single-arm, Phase II Clinical Study of Rituximab, Lenalidomide, and Zanubrutinib Combination Regimen Followed by Immunochemotherapy in the Treatment of Elderly Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: xi chen
- Phone Number: 17816890591
- Email: zjuchenxi@126.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Haiyan Yang, PhD
- Phone Number: 0086-571-88122192
- Email: yanghy@zjcc.org.cn
-
Contact:
- Xi Chen, MD
- Phone Number: 0086-571-88122192
- Email: zjuchenxi@126.com
-
Sub-Investigator:
- Xi Chen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
- Age: 70-85 years old, or 65-70 years old with ECOG score ≥2 points, both male and female.
- Histopathologically confirmed as diffuse large B-cell lymphoma, not otherwise specified.
- No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or anti-tumor growth factor).
- At least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET/CT examination showing increased uptake in lymph nodes or extranodal areas (higher than liver) and PET/CT and/or CT consistent with lymphoma; Measurable lesions: nodular lesions >15mm in length or extragendal lesions >10mm in length with increased FDG uptake).
Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency (no blood transfusion, granulocytic colony stimulating factor or other relevant medical support within 14 days prior to the use of the study drug) :
- neutrophil absolute count (ANC) ≥1.5×109/L (1500/mm3), platelet ≥75×109/L, hemoglobin ≥100g/L (if bone marrow is involved, platelet ≥50×109/L, ANC ≥1.0×109/L, hemoglobin ≥80g/L).
- Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST or ALT≤5 times the upper limit of normal value is allowed if liver is involved).
- Renal function: creatinine clearance ≥60 mL/min (estimated according to the Cockcroft-Gault formula).
- Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- Negative serum pregnancy test and effective contraceptive use from signing informed consent until 6 months after the last chemotherapy.
- Life expectancy > 3 months.
Exclusion Criteria:
- Pathological subtypes: primary central nervous system diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, high-grade B-cell lymphoma, not otherwise specified. EBV positive diffuse large B-cell lymphoma
- Hemophagocytic syndrome at the time of diagnosis.
- Central nervous system involvement secondary to lymphoma.
- Participating in other clinical studies.
- Medical history of other active malignancy within 2 years prior to enrollment, except for the following conditions:(1) adequately treated in situ of the cervix carcinoma; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- History of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome. Patients with positive hepatitis B surface antigen or hepatitis C virus antibody must be tested hepatitis B virus DNA (no more than 1000 iu/ml) and HCV RNA detection (below the detection limit). Patients with hepatitis B virus carriers, or stabilized hepatitis B with anti-virus treatment and cured hepatitis C can be included.
- Major surgery was performed within 28 days prior to study initiation.
- Any active infection, including bacterial, fungal or viral infections, that requires systemic antiinfection therapy within 14 days prior to treatment.
- Accompanied with severe or uncontrolled disease, including symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia A, hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.
- History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
- Patients who must take antiplatelet drugs and anticoagulants at the same time due to underlying diseases, and there is no alternative treatment plan.
- Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. Patients were excluded if they had taken a CYP3A potent or moderate-acting inhibitor or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).
- Hypersensitivity to the experimental drug is known.
- Patients deemed unsuitable for the study by researchers.
Study Plan
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: Rituximab, lenalidomide, zanubrutinib and RCHOP
Rituximab, lenalidomide, zanubrutinib for 2 cycles: rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-10, zanubrutinib 160mg bid. RCHOP for 4 cycles: rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5. |
chemo free period (21 days as a cycle, a total of 2 cycles): rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-10, zanubrutinib 160mg bid. Immunochemotherapy period: RCHOP regimen (21 days as 1 cycle, a total of 4 cycles): rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 21days after the end of treatment
|
overall response rate
|
21days after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: From date of first day of treatment until the date of first documented progression, assessed up to 24 months
|
Progression Free Survival
|
From date of first day of treatment until the date of first documented progression, assessed up to 24 months
|
OS
Time Frame: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
|
Overall Survival
|
From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
|
AE and SAE
Time Frame: From date of first day of treatment until 30 day after last treatment
|
Adverse event and serious adverse event
|
From date of first day of treatment until 30 day after last treatment
|
Performance status
Time Frame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
|
Assess the patient's performance status according to the Barthel index.
Patients will be classified into 5 scales with the score ranging from 0 to 100: 0-20 points=extremely severe functional impairment; 25-45 points=severe functional impairment; 50-70 points=moderate functional impairment; 75-95 points=mild functional impairment; 100 points=normal.
Higher scores mean a better outcome.
|
At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
|
Life quality
Time Frame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
|
Assess the patient's quality of life according to the EORTC QLQ-C30 questionnaire.
Higher scores mean a worse outcome.
|
At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Haiyan Yang, Zhejiang Cancer Hospital, Hangzhou, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Lenalidomide
- Rituximab
- Zanubrutinib
Other Study ID Numbers
- ZR2+RCHOP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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