Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.
Detailed description
The investigators will evaluate safety and efficacy of G-Pola-ZLP 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.
Interventions
DRUGGlofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone as Induction Therapy
Patients were treated by Glofitama(Cycle 1: D8, 2.5mg, D15, 10mg; followed by the target dose of 30mg on D1 of Cycle 2-12), Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 1 year | ORR was defined as the proportion of patients who achieved CR or PR as their best response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | through study completion, an average of 2 years | OS was defined as time from diagnosis to death from any cause or the last follow-up |
| Progression Free Survival (PFS) | 2 years | Progression was defined according to the Lugano Response Criteria |
Contacts
Primary ContactLiren Qian, PhD
Backup ContactLiren Qian, PhD
Outcome results
None listed