Zanubrutinib for treating recurrent mantle cell lymphoma

A Prospective, Open, Multicenter Clinical Observational Study of Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma

This study is testing if zanubrutinib can help people with recurrent mantle cell lymphoma who haven't had success with other treatments.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Drugs / interventions: Zabutinib, ortozumab
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05486013 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of zanubrutinib, a second-generation BTK inhibitor, in patients with recurrent and refractory mantle cell lymphoma (MCL). MCL is a type of B-cell lymphoma that often presents at an advanced stage and has a high rate of relapse after treatment. The study aims to determine how well zanubrutinib can improve outcomes for patients who have not responded to previous therapies. By focusing on patients at high risk of drug resistance, the research seeks to enhance treatment strategies for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with recurrent or refractory mantle cell lymphoma who have previously undergone treatment.

Not a fit: Patients with severe mental or neurological disorders that impair their ability to provide informed consent or those currently enrolled in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with recurrent mantle cell lymphoma.

How similar studies have performed: Previous studies have shown that BTK inhibitors like zanubrutinib can be effective in treating recurrent mantle cell lymphoma, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

1. Patients who have been enrolled in other clinical trials.
2. Patients who are receiving immunosuppressive therapy for other diseases.
3. Patients who have received other treatments for lymphoma before joining the group.
4. Complicated with other malignant tumors.
5. The researchers determined that the patients were not suitable for the study.
6. Severe mental or neurological disorders that affect informed consent or expression of adverse reactions.
7. Patients who cannot be followed up.

Exclusion Criteria:

1. Patients who have been enrolled in other clinical trials.
2. Patients who are receiving immunosuppressive therapy for other diseases.
3. Patients who have received other treatments for lymphoma before joining the group.
4. Complicated with other malignant tumors.
5. The researchers determined that the patients were not suitable for the study.
6. Severe mental or neurological disorders that affect informed consent or expression of adverse reactions.
7. Patients who cannot be followed up.

Exit (drop-off) criteria :

1. Subject requires to quit.
2. Serious adverse events occurred during the trial, so it is inappropriate to continue the trial.
3. Due to the progression of the disease during the trial, it is not appropriate to continue to use the trial drugs and / or to continue this study program.
4. Incomplete research data records.
5. Patients who cannot be followed up.

Withdrawal cases should be retained for future reference and transferred from the last record to the final record for ITT analysis.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Hongmei T Jing, Ph.D

Conditions Mantle Cell Lymphoma