Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

NCT06669143 | Not Yet Recruiting Phase 2

• 1 other identifier: zanubrutinib-based maintenance
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

DLBCL; zanubrutinib; maintenance

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival

  2 years after enrollment

Secondary Outcomes (3)

• Overall survival

  From enrollment to study completion, a maximum of 4.5 years

• Overall response rate

  up to 2 year, at the end of maintenance

• Complete response rate

  up to 2 year, at the end of maintenance

Study Arms (1)

Zanubrutinib and Lenalidomide

EXPERIMENTAL

Drug: Zanubrutinib; Drug: Lenalidomide

Interventions

Zanubrutinib DRUG

160 mg bid, po, day 1-21, a maximum of 2 years.

Zanubrutinib and Lenalidomide

Lenalidomide DRUG

25 mg qd, po, day 1-10, a maximum of 2 years.

Zanubrutinib and Lenalidomide

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients were informed about this study and voluntarily signed written informed consent
• Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
• DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
• Life expectancy \> 3 months
• Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.

You may not qualify if:

• Contraindication to any drug in the study
• Seropositive for or active viral infection with HBV or HCV
• Human immunodeficiency virus (HIV) infection
• Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
• QTc (corrected by Fridericia formula): \>480ms;
• Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
• If female, the patient is pregnant or breast-feeding
• Any uncontrolled active systemic infection

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinib; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Weili Zhao, M.D. and Ph.D

CONTACT

021-64370045; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 1, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10