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Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma

ConditionMarginal Zone Lymphoma(MZL)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhengzhou University

About this trial

The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies.

Participants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years

Histologically confirmed MZL in untreated stage III or IV and needed for therapy as determined by the treating physician

ECOG performance status 0-2

Expected survival ≥ 6 months

Disqualifiers

Pregnant or lactating women

Active central nervous system lymphoma

Previous anti-tumor treatment

A severe immediate-type hypersensitivity reaction history for any of the drugs used in this study

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma

    Drug

    This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.

  • Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma

    Drug

    This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone LymphomaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

CRR

Complete remission rate

Time frame
2 years

Secondary outcomes

1

ORR

Objective response rate

Time frame
2 years
2

2 year-progress free survival rate

the time from the start of treatment to the time when the patient has progressed on the disease or dies due to any cause in 2 years.

Time frame
2 years
3

TTR

Time from randomization to the first documentation of Complete Response (CR) or Partial Response (PR) , verified by computed tomography (CT) and positron emission tomography (PET)-CT at least 6 weeks apart

Time frame
From randomization up to 24 months post-randomization
4

DoR

The interval from the date of first confirmed OR to the first evidence of progressive disease or death from any cause

Time frame
From the date of first confirmed CR/PR up to 24 months post-confirmed response

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhengzhou University

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: