Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma
NCT ID: NCT05504603
Last Updated: 2022-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-07-27
2025-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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zanubrutinib(80mg), rituximab(100mg), ASCT
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
zanubrutinib and rituximab
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
zanubrutinib and rituximab
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
BEAM pretreatment
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
zanubrutinib maintenance
zanubrutinib 160mg PO BID.
Interventions
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zanubrutinib and rituximab
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
zanubrutinib and rituximab
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
BEAM pretreatment
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
zanubrutinib maintenance
zanubrutinib 160mg PO BID.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Jinzm 004
Identifier Type: -
Identifier Source: org_study_id
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