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

NCT06516978 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2024-07-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Polatuzumab vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Orelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

Venetoclax

Venetoclax PO will be administered as per the schedule specified in the respective arm.

DRUG

Chidamide

Chidamide PO will be administered as per the schedule specified in the respective arm.

DRUG

Penpulimab

Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-10-01
Completion
2029-04-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516978 on ClinicalTrials.gov