Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

NCT ID: NCT06503263

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maintenance Therapy

Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy

Group Type EXPERIMENTAL

Zanubrutinib plus Lenalidomide as Maintenance Therapy

Intervention Type 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

No maintenance Therapy

Patients received no maintenance Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zanubrutinib plus Lenalidomide as Maintenance Therapy

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

Intervention Type DRUG

Other Intervention Names

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Zanubrutinib plus Lenalidomide

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Liren Qian

Vice Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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[email protected] Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Locations

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Navy General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liren Qian, PhD

Role: CONTACT

+861066947192

Facility Contacts

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Liren Qian, M.D.

Role: primary

+861066947194

Other Identifiers

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ZLDLBCL2024

Identifier Type: -

Identifier Source: org_study_id

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