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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06516978
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab vedotin — DRUG
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
  • Rituximab — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Cyclophosphamide — DRUG
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
  • Doxorubicin — DRUG
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
  • Vincristine — DRUG
    Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
  • Prednisone — DRUG
    Prednisone PO will be administered as per the schedule specified in the respective arm.
  • Orelabrutinib — DRUG
    Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
  • Venetoclax — DRUG
    Venetoclax PO will be administered as per the schedule specified in the respective arm.
  • Chidamide — DRUG
    Chidamide PO will be administered as per the schedule specified in the respective arm.
  • Penpulimab — DRUG
    Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
  • Lenalidomide — DRUG
    Lenalidomide PO will be administered as per the schedule specified in the respective arm.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Jul 2024
Primary completion
Oct 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
528 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pola-RCHP-X
    From cycles 1 to 6, patients will receive Polatuzumab Vedotin 1.8 mg/kg, Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², and Doxorubicin 50 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle.
  • Active Comparator: RCHOP-X
    From cycles 1 to 6, patients will receive Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², Doxorubicin 50 mg/m², and Vincristine 1.4 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle.
  • Active Comparator: Pola-RCHP
    From cycles 1 to 6, patients will receive Polatuzumab Vedotin at 1.8 mg/kg, Rituximab at 375 mg/m², Cyclophosphamide at 750 mg/m², and Doxorubicin at 50 mg/m² on day 1 of each cycle, and Prednisone at 100 mg/day from days 1 to 5. In cycles 7 to 8, patients will receive Rituximab at 375 mg/m² on day 1 of each cycle.

Primary Outcome Measure

Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [ Time Frame: At 24 months ]

Central Contacts

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