Clinical trial · Interventional
Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
A Phase 2 Study of Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
NCT05504603CI-TRIAL-00060370unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.
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 |
|---|---|---|---|
| Untreated Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAM pretreatment | Drug | — | UNRESOLVED |
| zanubrutinib and rituximab | Drug | — | UNRESOLVED |
| zanubrutinib maintenance | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- zanubrutinib(80mg), rituximab(100mg), ASCT
- description
- 1. Phase I(Combined Immunotherapy Phase): Part A(Induction Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1,8,15,22. Part B(Consolidation Immunotherapy Phase): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for 4 cycles. 2. Phase II(ASCT): BEAM pretreatment. Patients receive semustine on day1, etoposide on days 2-5, cytarabine on days 2-5 and melphalan on day 6. 3. Phase III(maintenance): Zanubrutinib
- interventionNames
- Drug: zanubrutinib and rituximab
- Drug: BEAM pretreatment
- Drug: zanubrutinib maintenance
Primary outcomes (4)
- measure
- Overall Response Rate(ORR) in all patients
- timeFrame
- At the end of cycle 3 and cycle 5(each cycle is 28 days)
- description
- The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases; 2. Initial untreated patients; 3. Age ≥ 18 years; 4. ECOG score 0-2; 5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. Male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter; 6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination); 7. Written informed consent obtained from the subject. Exclusion Criteria: 1. Indolent Mantle Cell Lymphoma; 2. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal) 3. Uncontrolled active infection, with the exception of tumor-related B symptom fever; 4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2); 5. Co-existence of other tumors; 6. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.