A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
NCT ID: NCT05933967
Last Updated: 2023-08-15
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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RECRUITING
PHASE2
31 participants
INTERVENTIONAL
2023-06-01
2026-12-30
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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orelabrutinib+R-CHOP
Orelabrutinib+R-CHOP
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.
Interventions
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Orelabrutinib+R-CHOP
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.
Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years
* ECOG performance status 0-2
* Ann Arbor stage II-IV
* 8.Subjects who in line with the testing standard of the clinical trial laboratory
* Life expectancy ≥ 3months
Exclusion Criteria
* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
* uncontrolled infections (including HBV, HCV, HIV/AIDS)
* Subjects who prepared for transplantation
* Pregnancy or active lactation
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Nanchang University
OTHER
Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Zengjun Li
Head of the Hematology Department
Principal Investigators
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zengjun Li
Role: STUDY_CHAIR
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Locations
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The First Ailliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China
Countries
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Central Contacts
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Dan Liu
Role: CONTACT
Facility Contacts
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Fei Li
Role: primary
zengjun Li
Role: primary
Other Identifiers
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SDCHI-NHL-001
Identifier Type: -
Identifier Source: org_study_id
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