Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

NCT06503263 | Recruiting Phase 2

• 1 other identifier: ZLDLBCL2024
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• EFS

  EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.

  2 years

Secondary Outcomes (2)

• PFS

  2 years

• OS

  2 years

Study Arms (2)

Maintenance Therapy

EXPERIMENTAL

Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy

Drug: Zanubrutinib plus Lenalidomide as Maintenance Therapy

No maintenance Therapy

NO INTERVENTION

Patients received no maintenance Therapy

Interventions

Zanubrutinib plus Lenalidomide as Maintenance Therapy DRUG

Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd d1-14) as maintenance therapy until 2 years post chemotherpay

Also known as: Zanubrutinib plus Lenalidomide

Maintenance Therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
• Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
• Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
• Patient has recieved complete remission and has completed planed courses of chemotherapy
• Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months

You may not qualify if:

• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
• Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
• Pregnant or lactating women

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinib; Lenalidomide; Maintenance

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; Health Care Facilities Workforce and Services

Study Officials

• qlr2007@126.com Qian, PhD

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066947192; qlr2007@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)