A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 308

Inclusion Criteria

Patients with histologically-confirmed, Ann Arbor stage II – IVA CD20+ Follicular Lymphoma (FL) (Grades 1, 2, or 3a), aged at least 18 years, not previously treated for their FL, low tumor burden according to Groupe D’Etude des Lymphomes Folliculaires (GELF) criteria, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, at least one measurable lesion per the International Working Group (IWG) criteria 2007 at screening, no evidence of transformation to a large cell histology, and adequate hematological, renal, and liver function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 274
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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. Leukemia or transformation to diffuse large B cell lymphoma secondary to previously untreated follicular 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.
? Patients with a negative HBsAg and positive HBcAb must have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level <20 IU/mL (or 112 copies/mL) by polymerase chain reaction (PCR). These HBV patients must be willing to undergo PCR HBV DNA testing during treatment and may participate following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated. An HBV re-test will be performed at each study visit from Week 5 onwards, and at the discretion of the Investigator.
? Patients with a positive test because of HBV vaccine may be included (i.e., anti-HBs+, anti-HBc–).
? Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA).
12. Confirmed current active tuberculosis (TB). Patients with latent TB as determined by tuberculosis skin testing (e.g. Mantoux test) or interferon-gamma release assay (IGRA e.g.QuantiFERON-TB test) may be enrolled if such patients have written confirmation from their health care provider (e.g., Pulmonologist or Infection Specialist) of adequate prophylaxis before or within the screening period, and no evidence of tuberculosis on a chest X-ray performed within 3 months of Day 1 or chest CT.
13. Central nervous system (CNS) or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma. A brain (CT or MRI) scan should be conducted at screening ONLY if lesions are suspected on the brain, to exclude patients with brain localization of FL.
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 As

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera®, brand name in EU) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL).;Secondary Objective: To evaluate SAIT101 versus MabThera® with respect to:<br>•Safety and tolerability;<br>•Immunogenicity;<br>•Pharmacokinetics (PK) and pharmacodynamics (PD) in a sub population of patients.;Primary end point(s): Primary Efficacy Endpoint:<br>Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28 as defined by IWG criteria 2007;Timepoint(s) of evaluation of this end point: at Week 28 as defined by IWG criteria 2007

Secondary Outcome Measures

Name	Time	Method

A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphoma

Recruitment & Eligibility

Study & Design

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