Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

Sponsor
Hoffmann-La Roche
Study ID
NCT02406092
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab SC 1400 mg
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as per standard local practice.
  • Doxorubicin — DRUG
    Doxorubicin will be administered as per standard local practice.
  • Vincristine — DRUG
    Vincristine will be administered as per standard local practice.
  • Prednisone — DRUG
    Prednisone will be administered as per standard local practice.
  • Fludarabine — DRUG
    Fludarabine will be administered as per standard local practice.

Study Details

This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).

Key Dates

Start date
Oct 13, 2015
Status verified
Nov 2024
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

Enrollment
139 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.

Primary Outcome Measure

Percentage of Participants With Administration-Associated Reactions (AARs) [ Time Frame: Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants) ]

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