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New treatment option for Mantle Cell Lymphoma
Official title A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT06341556
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as Maintenance therapy with Zanubrutinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old;
- Histologically confirmed mantle cell lymphoma (MCL);
- Achieved complete response (CR) or partial response (PR) through first-line sufficient treatment (including immunochemotherapy with CD20 monoclonal...
- ECOG 0-2;
- Signed informed consent form;
You likely can't join if
- Individuals who are allergic to human or mouse monoclonal antibodies and have been confirmed to be allergic to Zanubrutinib capsules and/or their...
- Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
- Uncontrollable concurrent diseases (cardiovascular and cerebrovascular diseases, blood coagulation disorders, severe infectious diseases) include but...
- Serious accompanying diseases that interfere with conventional treatment;
- Has a history of active malignant tumors. Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell...
- Known to have active interstitial pneumonia;
See the full eligibility criteria
- Age ≥ 18 years old;
- Histologically confirmed mantle cell lymphoma (MCL);
- Achieved complete response (CR) or partial response (PR) through first-line sufficient treatment (including immunochemotherapy with CD20 monoclonal antibody for at least 4 cycles). Frontline induction programs include...
- ECOG 0-2;
- Signed informed consent form;
- Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST\<3 x ULN, serum...
- Individuals who are allergic to human or mouse monoclonal antibodies and have been confirmed to be allergic to Zanubrutinib capsules and/or their excipients;
- Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
- Uncontrollable concurrent diseases (cardiovascular and cerebrovascular diseases, blood coagulation disorders, severe infectious diseases) include but are not limited to: severe acute or chronic infections requiring...
- Serious accompanying diseases that interfere with conventional treatment;
- Has a history of active malignant tumors. Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma in situ who have received possible curative...
- Known to have active interstitial pneumonia;
- Known cases of alcohol or drug abuse;
- Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive...
- Patients with active HIV and syphilis infections;
- Pregnant or lactating women;
- live vaccine administered within 4 weeks prior to administering the investigational drug, inactivated virus vaccines such as for seasonal influenza are allowed;
- Continuous corticosteroid treatment currently being received, with a dose greater than 30mg/day of prednisone or equivalent medication for at least 10 days of continuous treatment;
- Suffering from active autoimmune diseases that require systematic treatment within the past 2 years (Hormone replacement therapy is not considered as a systematic treatment, such as type I diabetes, hypothyroidism...
- Patients with swallowing disorders who are unable to take medication orally for a long time;
- Individuals with mental disorders who affect compliance and are unable to obtain informed consent;
- The researcher determined that patients are not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.