A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT04914741
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle
  • Doxorubicin — DRUG
    Doxorubicin 50mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle
  • Vincristine — DRUG
    Vincristine 1.4mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle
  • Prednisolone — DRUG
    Prednisolone 100mg orally on Days 1-5 of every 21-day cycle
  • Glofitamab — DRUG
    Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm
  • Polatuzumab vedotin — DRUG
    Polatuzumab 1.8mg/kg administered by IV infusion on Day 1 of every 21-day cycle

Study Details

This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.

Key Dates

Start date
Jun 29, 2021
Status verified
Aug 2024
Primary completion
Dec 5, 2023
Completion
Jul 31, 2025

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab plus R-CHOP
    Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by R-CHOP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion.
  • Experimental: Glofitamab plus polatuzumab vedotin-RCHP
    Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by polatuzumab vedotin-RCHP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion.

Primary Outcome Measure

To assess safety of the combination of glofitamab and R-CHOP or pola-RCHP according to number of participants with treatment-related adverse events [ Time Frame: From start of treatment till the end of study, assessed up to approximately 60 months ]

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