A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor
Hoffmann-La Roche
Study ID
NCT04660799
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

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

Interventions

  • Rituximab IV — DRUG
    Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m\^2 (milligram per square meter).
  • Rituximab SC — DRUG
    Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg).
  • Rituximab IV — DRUG
    Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m\^2.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered IV at a dose of 750 mg/m\^2
  • Doxorubicin — DRUG
    Doxorubicin will be administered IV at a dose of 50 mg/m\^2
  • Vincristine — DRUG
    Vincristine will be administered IV at a dose of 1.4 mg/m\^2
  • Prednisone — DRUG
    Prednisone will be administered orally at a dose of 100 mg/day
  • Paracetamol — DRUG
    All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab
  • Diphenhydramine hydrochloride or alternative antihistamine — DRUG
    All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab

Study Details

This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV combined with six or eight cycles of standard CHOP chemotherapy. After the end of study treatment, participants will be followed-up every 3 months for 6 months.

Key Dates

Start date
Feb 24, 2021
Status verified
Sep 2023
Primary completion
May 23, 2022
Completion
Oct 11, 2022

Study Design

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

Arms

  • Active Comparator: Rituximab IV+CHOP
    Participants will receive 8 cycles of IV rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.
  • Experimental: Rituximab SC+CHOP
    Participants will receive 1 cycle of IV plus 7 cycles of SC rituximab in combination with 6 or 8 cycles of CHOP chemotherapy administered every 3 weeks.

Primary Outcome Measure

Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV) [ Time Frame: At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks ]

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