A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: SAIT101; MabThera®
Intervention description: Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22; Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
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: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low tumor burden follicular lymphoma (LTBFL)

Summary:

      This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the
      statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as
      a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden
      Follicular Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B
             symptoms, Ann Arbor stage II to Non-Hodgkin's Lymphoma (NHL) (CD20+ Follicular
             Lymphoma of Grades 1, 2, or 3a)

          2. Low tumor burden according to The Groupe d'Etude des Lymphomes Folliculaires (GELF)
             criteria defined as:

               -  Normal serum lactate dehydrogenase (LDH)

               -  No mass ≥7 cm.

               -  Less than 3 nodal sites, each with diameter >3 cm

               -  No systemic or B symptoms (fever >38°C for 3 consecutive days; recurrent,
                  drenching night sweats; unintentional weight loss exceeding 10% body weight in
                  the last 6 months.

               -  No splenomegaly ≥16 cm by CT scan.

               -  No risk of vital organ compression.

               -  No pleural or peritoneal serous effusion.

               -  No leukemic phase >5,000/µL circulating tumor cells.

               -  No cytopenias (defined as platelets <100,000/mm3, hemoglobin <10 g/dL, or
                  absolute neutrophil count <1,500/mm3).

          3. Patients not previously treated for their FL, including any previous treatment for FL
             under clinical trials except localized radiation therapy for previous limited stage
             disease.

        Exclusion Criteria:

          1. Previous treatment with any chemotherapy and/or rituximab or other monoclonal
             antibody.

          2. Prior radiotherapy completed <28 days before study enrollment.

          3. Anticipated need for concomitant administration of any other experimental drug, or a
             concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy
             during study participation.

          4. Concomitant disease which requires continuous therapy with corticosteroids at doses
             equivalent to prednisolone >20 mg/day.

          5. Transformation to high-grade lymphoma secondary to previously untreated low-grade
             lymphoma.

          6. Prior or concomitant malignancies within 5 years prior to screening, with the
             exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the
             cervix, adequately treated breast cancer in situ, and localized prostate cancer stage
             T1c, provided that the patient underwent curative treatment and remains relapse free.

          7. Patients with a body surface area >3.0 m2.

          8. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.

          9. Primary or secondary immunodeficiency (history of, or currently active), including
             known history of human immunodeficiency virus (HIV) infection or positive test at
             screening.

         10. Acute, severe infection (e.g., sepsis and opportunistic infections), or active,
             chronic or persistent infection that might worsen with immunosuppressive treatment
             (e.g., herpes zoster).

         11. Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core
             antibody (HBcAb) or hepatitis C serology.

         12. Confirmed current active tuberculosis (TB)

         13. Central nervous system (CNS) or meningeal involvement, or cord compression by the
             lymphoma; history of CNS lymphoma

         14. History of a severe allergic reaction or anaphylactic reaction to a biological agent
             or history of hypersensitivity to any component of the trial drug (e.g.,
             hypersensitivity or allergy to murine products).

         15. Patients who have significant cardiac disease, including but not limited to history of
             congestive heart failure (New York Heart Association Class III/IV; see Appendix 7),
             unstable angina, or uncontrolled cardiac arrhythmia.

         16. Uncontrolled or severe hypertension, or cerebrovascular disease.

         17. Serious underlying medical conditions that, per the Investigator's discretion, could
             impair the ability of the patient to participate in the trial

         18. Any other co-existing medical or psychological condition(s) that will preclude
             participation in the study or compromise ability to give informed consent and/or
             comply with study procedures.

         19. Treatment with any investigational medicinal product (IMP) within 4 weeks prior to
             initiation of 1st infusion of study drug, or treatment with a drug that has not
             received regulatory approval for any indication within 4 weeks or a minimum of 5
             half-lives, whichever is longer, of the 1st infusion of study drug.

         20. Receipt of a live/attenuated vaccine within 6 weeks prior to the screening visit.

         21. Females who are pregnant, breastfeeding, or planning a pregnancy during the treatment
             period or within 12 months after the last infusion of study drug.

         22. Patients who are investigational site staff members directly involved in the conduct
             of the trial, and their family members, site staff members otherwise supervised by the
             investigator, or patients who are Archigen employees directly involved in the conduct
             of the trial.