NCT06136351RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 25 Sept 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT06136351
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 23
- From 15 Nov 2023 to the primary completion date, 1 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
- 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;
Lab values
- With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
Other
- Pregnant or lactating women;
- With acquired or congenital immunodeficiency;
- Deemed unsuitable for the group.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.