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Recruiting

NCT Number: NCT06136351

A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

Location status: Recruiting

Location contact

Weili ZHAO

CONTACT

[email protected]

+862164370045 ext. 610707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years
  • Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
  • FISH with del(17p)/TP53 mutation or ≥65 years; or<65 years but chemotherapy intolerance;
  • Life expectancy of > 3 months (in the opinion of the investigator);
  • Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m^2);
  • International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
  • Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Exclusion criteria

  • Pregnant or lactating women;
  • Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA > detectable limit);
  • With acquired or congenital immunodeficiency;
  • With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF < 50%;
  • Known to be allergic to the test drug ingredients;
  • Diagnosed with or being treated for malignancy other than lymphoma;
  • With severe infection;
  • Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
  • Deemed unsuitable for the group.

Treatment and study plan

Zanubrutinib

Drug

160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up

Rituximab

Drug

375 mg/m^2 ivgtt, D0 of each 28-day cycle

Bendamustin

Drug

90mg/m^2 ivgtt, D0 of each 28-day cycle

Primary outcomes

  1. 2-year Progression-Free Survival

    Time frame: 2 years

    Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.

Secondary outcomes

  1. ORR

    Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]

    Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)

  2. CRR

    Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]

    Complete Remission Rate (CRR) is defined as the proportion of patients with CR

  3. OS

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    Overall survival (OS) refers to the time from receiving the first dose to death from any cause

  4. Adverse Events

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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