Diffuse Large B Cell Lymphoma
Conditions
Brief summary
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
Interventions
DRUGPolatuzumab vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
DRUGRituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
DRUGCyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUGDoxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUGVincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUGPrednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
DRUGOrelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
DRUGVenetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
DRUGChidamide
Chidamide PO will be administered as per the schedule specified in the respective arm.
DRUGPenpulimab
Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
DRUGLenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Sign the informed consent form * Previously untreated participants with CD20-positive DLBCL * Life expectancy ≥ 6 months * IPI score 2-5 * ECOG Performance Status of 0, 1, or 2 * Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows: Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment ANC ≥ 1.0 x 10\^9/L PLT ≥ 75 x 10\^9/L
Exclusion criteria
* Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 * History of other malignancy that could affect compliance with the protocol or interpretation of results * Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina * History or presence of an abnormal ECG that is clinically significant in the investigator's opinion * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety * Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): Serum AST and ALT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN Serum creatinine clearance \< 40 mL/min (using Cockcroft-Gault formula) * Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay) * Participants with a history of progressive multifocal leukoencephalopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | At 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] |
| Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] |
| Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | up to approximately 48 months |
| Overall Survival (OS) | up to approximately 48 months |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From enrollment to study completion, a maximum of 48 months |
Contacts
Primary ContactWei Xu
Outcome results
None listed