Clinical trial · Observational
Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma
A Prospective, Open, Multicenter Clinical Observational Study of Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
80% of patients with mantle cell lymphoma (mantle cell lymphoma, MCL)were in the advanced tumor stage when they were first diagnosed. Zabutinib, as a new generation of BTK inhibitors, has better targeting and safety in clinical application. Previous studies have confirmed that zabutinib has good efficacy in treating relapsed refractory MCL. However, for patients with a high risk of drug resistance to BTK inhibitors or patients with drug resistance, the efficacy of BTK inhibitors alone is poor, and combined therapy can improve the poor prognosis of these patients. Therefore, the primary purpose of this study is to evaluate the safety and efficacy of zebutenil in treating recurrent, refractory mantle cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The objective response rate
- timeFrame
- From the time of the first drug administration until the end of two cycles (each cycle is 28 days)
- description
- This trial's primary outcome is the objective response rate (ORR) of two cycles of treatment
Secondary outcomes (1)
- measure
- The negative rate of minimal residual disease
- timeFrame
- From the first day of medication to the end of 1 year
- description
- The secondary outcome of this trial is 1-year negative rate of minimal residual disease(MRD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available