Last updated: November 24, 2023
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Lymphoma
Treatment
Bendamustin
Rituximab
Zanubrutinib
Clinical Study ID
NCT06136351
ZBR-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years
- Histopathologically confirmed mantle cell lymphoma according to the 5th editionof the World Health Organization (WHO)
- FISH with del(17p)/TP53 mutation or ≥65 years; or<65 years but chemotherapyintolerance;
- 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 ThromboplastinTime (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 orprocedure for the research on their own or legal representative.
Exclusion
Exclusion Criteria:
- Pregnant or lactating women;
- Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infectionrefers to HBV-DNA > detectable limit);
- With acquired or congenital immunodeficiency;
- With congestive heart failure in 6 months before enrollment, New York HeartAssociation (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 withthe subjects' participation in the study or evaluation of the study results;
- Deemed unsuitable for the group.
Study Design
Total Participants: 23
Treatment Group(s): 3
Primary Treatment: Bendamustin
Phase: 2
Study Start date:
November 15, 2023
Estimated Completion Date:
November 01, 2027
Connect with a study center
Ruijin Hospital
Shanghai, Shanghai 200020
ChinaActive - Recruiting
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