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Trial Title:
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
NCT ID:
NCT06136351
Condition:
Lymphoma, Mantle-Cell
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Bendamustine Hydrochloride
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
160 mg bid po, until disease progression, intolerance of drug toxicity or death,
otherwise maintaining during the 2 years of follow-up
Arm group label:
ZBR
Intervention type:
Drug
Intervention name:
Rituximab
Description:
375 mg/m^2 ivgtt, D0 of each 28-day cycle
Arm group label:
ZBR
Intervention type:
Drug
Intervention name:
Bendamustin
Description:
90mg/m^2 ivgtt, D0 of each 28-day cycle
Arm group label:
ZBR
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital
Address:
City:
Shanghai
Zip:
200020
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili ZHAO
Phone:
+862164370045
Phone ext:
610707
Email:
zwl_trial@163.com
Start date:
November 15, 2023
Completion date:
November 1, 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136351
