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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZBR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | 160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-Free Survival | Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR) | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days] |
| CRR |
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Inclusion Criteria:
18 years
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| Rituximab | Drug | 375 mg/m^2 ivgtt, D0 of each 28-day cycle |
|
| Bendamustin | Drug | 90mg/m^2 ivgtt, D0 of each 28-day cycle |
|
Complete Remission Rate (CRR) is defined as the proportion of patients with CR
| End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days] |
| OS | Overall survival (OS) refers to the time from receiving the first dose to death from any cause | Baseline up to data cut-off (up to approximately 2 years) |
| Adverse Events | Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment. | Baseline up to data cut-off (up to approximately 2 years) |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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