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Trial Title:
Pola-ZR2P in Previously Untreated DLBCL
NCT ID:
NCT06664411
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Prednisone
Rituximab
Lenalidomide
Zanubrutinib
Polatuzumab vedotin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy
Description:
Patients were treated by Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po
bid d1-21), Rituximab(375mg/m2 iv qd d1), Lenalidomide(25mg po qd d1-14) and
Prednisone(60mg/m2 po qd d1-5) as induction therapy
Arm group label:
Pola-ZR2P
Other name:
Pola-ZR2P
Summary:
The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as
induction therapy in patients with DLBCL.
Detailed description:
The investigators will evaluate safety and efficacy of Pola-ZR2P as induction therapy in
Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate,
progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be
assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health
Organization (WHO) classification;
- Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Patient must understand and voluntarily sign an ICF prior to any study-specific
assessments/procedures being conducted;
- Patient is willing and able to adhere to the study visit schedule and other protocol
requirements;
- Patient has not received chemotherapy previously.
- Anticipated life expectancy at least 3 months
Exclusion Criteria:
- Active or uncontrolled infections requiring systemic treatment within 14 days before
enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac,
liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Navy General Hospital
Address:
City:
Beijing
Zip:
100048
Country:
China
Start date:
December 2024
Completion date:
December 2030
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06664411
