A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

Trial Title: A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

NCT ID: NCT06516978

Condition: Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Lenalidomide
Venetoclax
Polatuzumab vedotin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Polatuzumab vedotin
Description: Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP
Arm group label: Pola-RCHP-X

Intervention type: Drug
Intervention name: Rituximab
Description: Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Doxorubicin
Description: Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Vincristine
Description: Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Prednisone
Description: Prednisone PO will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Orelabrutinib
Description: Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Venetoclax
Description: Venetoclax PO will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Chidamide
Description: Chidamide PO will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Penpulimab
Description: Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

Intervention type: Drug
Intervention name: Lenalidomide
Description: Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Arm group label: Pola-RCHP-X
Arm group label: RCHOP-X

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: October 1, 2024

Completion date: April 1, 2029

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06516978