Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: ABP 798; Rituximab
Intervention description: ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.; Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CD20 Positive B-cell Non-Hodgkin Lymphoma; ABP 798

Summary:

      This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity
      study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and
      immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a
      follicular B-cell NHL and low tumor burden.

      Subjects were randomized in a 1:1 ratio to receive a 375 mg/m^2 intravenous infusion of
      either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years of age and older

          -  Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a
             follicular B-cell NHL expressing CD20 within 12 months before randomization

          -  Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with
             measurable disease (per International Working Group)

               -  subjects must have a baseline scan (computed tomography [CT]) of the neck (if
                  palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease
                  burden within 6 weeks before randomization

               -  subjects must have had a baseline bone marrow biopsy within 12 months before
                  randomization. Previously confirmed positive bone marrow involvement does not
                  need to be repeated for purposes of screening.

          -  Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF)
             criteria

               -  largest nodal or extranodal mass ≤ 7 cm

               -  no more than 3 nodal sites with diameter > 3 cm

               -  no splenomegaly > 16cm by CT scan and no symptomatic splenomegaly

               -  no significant pleural or peritoneal serous effusions by CT

               -  lactate dehydrogenase ≤ upper limit of normal (ULN)

               -  no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the
                  previous 6 months)

        Exclusion Criteria:

          -  Diffuse large cell component and/or Grade 3b follicular NHL

          -  History or known presence of central nervous system metastases

          -  Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or
             squamous or basal cell carcinoma of the skin)

          -  Recent infection requiring a course of systemic anti-infective agents that was
             completed ≤ 7 days before randomization (with the exception of uncomplicated urinary
             tract infection)

          -  Other investigational procedures that can impact the study data, results, or patient
             safety while participating in this study are excluded; participation in observational
             studies is allowed.

          -  Subject is currently enrolled in or has not yet completed at least 30 days or 5
             half-lives (whichever is longer) since ending other investigational device or drug
             study(s), including vaccines, or subject is receiving other investigational agent(s)

          -  Previous use of either commercially available or investigational chemotherapy,
             biological, or immunological therapy for NHL (including rituximab or biosimilar
             rituximab, or other anti-CD20 treatments)

          -  Systemic corticosteroid use within 3 months before randomization (inhaled are
             allowable)