Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

Last updated: August 16, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05504603
Jinzm 004
  • Ages > 18
  • All Genders

Study Summary

The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolentMantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification ofdiseases;
  2. Initial untreated patients;
  3. Age ≥ 18 years;
  4. ECOG score 0-2;
  5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior tostudy entry, for the duration of study participation, and for 12 months thereafter.Male patients must agree that their spouses will not become pregnant during the studyperiod and for 12 months thereafter;
  6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skinlesions assessed by physical examination);
  7. Written informed consent obtained from the subject.

Exclusion

Exclusion Criteria:

  1. Indolent Mantle Cell Lymphoma;
  2. Patients with severe liver and kidney dysfunction (alanine aminotransferase,bilirubin, creatinine > 3 times the upper limit of normal)
  3. Uncontrolled active infection, with the exception of tumor-related B symptom fever;
  4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
  5. Co-existence of other tumors;
  6. Any other psychological conditions that prevent patients from participating in thestudy or signing the informed consent form.

Study Design

Total Participants: 20
Study Start date:
July 27, 2020
Estimated Completion Date:
July 26, 2025

Study Description

The study will start with an initial 28-days of induction immunotherapy with ZR and 4 cycles of consolidation immunotherapy with ZR，following imaging examinations to evaluate response rates. Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status. The older or frail patients who are ineligible for ASCT will take zanubrutinib orally until intolerable toxicity or disease progression. Patients who are young and fit for transplantation will receive ASCT consolidation. After ASCT, patients with CR will end therapy and enter the follow-up stage, while patients with PR will continue to take zanubrutinib orally until intolerable toxicity or disease progression.

Connect with a study center

  • the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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