Health Condition 1: C829- Follicular lymphoma, unspecified Health Condition 2: null- Low Tumor Burden Follicular Lymphoma
Conditions
Interventions
Intervention1: SAIT101: 375 mg/m2 (dose) i.v infusion
Once a week for 4 weeks
Control Intervention1: MabThera®: 375 mg/m2 (dose) i.v infusion
Once a week for 4 weeks
Sponsors
Archigen Biotech Limited
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged at least 18 years. 2. Histologically-confirmed, without B symptoms, Ann Arbor stage II to IVA NHL (CD20 FL of Grades 1, 2, or 3a) (Appendix 5): - Patients can be entered based on a diagnosis of CD20 follicular lymphoma confirmed at the investigational site. Archival tissue or slides must be sent to the central pathology reviewer for retrospective confirmation of diagnosis. Patients must have tissue or slide available for the central pathology review to be enrolled. - Patients having both diffuse and follicular architectural elements will be considered eligible if the histology is predominantly follicular (i.e. greater than 50 percent â??sectional area), and there is no evidence of transformation to a large cell histology. - If the interval since tissue diagnosis of follicular lymphoma is more than 12 months, diagnostic confirmation using either core needle or excisional lymph node biopsy (latter preferred) is required to confirm that the histology remains in one of the eligible categories. Bone marrow biopsy alone is not acceptable. 3. Low tumor burden according to GELF criteria defined as: a) Normal serum lactate dehydrogenase (LDH) or beta2-microglobulin levels. b) No mass 7 cm. c) Less than 3 masses greater than 3 cm. d) No systemic or B symptoms (fever greater than 38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10 percent body weight in the last 6 months. e) No splenomegaly greater than 16 cm by CT scan. f) No risk of vital organ compression. g) No pleural or peritoneal serous effusion. h) No cytopenias (defined as platelets less than 100x109 L (100,000 mm3), hemoglobin less than 100g/L (10 g/dL), or absolute neutrophil count less than 1.5x109/L (1,500/mm3)). 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Have at least one measurable lesion as per the IWG criteria 2007 at screening (lesion clearly measurable in at least 2 perpendicular dimensions). 7. Adequate renal function: Creatinine clearance 0.835 mL/s (50 mL/min) (Cockroft-Gault formula) 8. Adequate liver function: total bilirubin less than 34 μmol/L (2.0 mg/dL) except for patients with Gilbertâ??s Syndrome or hemolysis. Aspartate aminotransferase (AST) and alanineaminotransferase (ALT) less than 3 Ã? upper limit of normal (ULN) (less than5 Ã? ULN is acceptable if abnormalities are thought to be related to hepatic infiltration by FL). - Patients with total bilirubin greater than 34 μmol/L (2.0 mg/dL) possibly due to Gilbertâ??s Syndrome should have a direct bilirubin checked. If the direct bilirubin is normal and medical history is suggestive/positive for Gilbertâ??s Syndrome, the patient successfully meets the criteria. 9. Men and women of childbearing potential must use 2 forms of accepted and highly effective methods of contraception during the course of the treatment period and for at least 12 months after the last infusion of study drug. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Examples of highly effective contrace
Exclusion criteria
Exclusion criteria: 1.Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody. 2.Prior radiotherapy completed 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 -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 scan CT or MRI 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera®) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL). Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28, as defined by International Working Group (IWG) criteria 2007. This will be assessed centrally. Timepoint: Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Complete Response (CR) -Partial Response (PR) - Stable Disease (SD) -Progressive disease (PD)Timepoint: Week 12 and 28;Overall response rateTimepoint: Week 12;Time to event (TTE), defined as the time from the date of randomization to the date when an event occursTimepoint: an event is disease progression, death due to any cause, or the start of new treatment for FL, whichever comes first | — |
Countries
Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Democratic People's Republic of Korea, Egypt, France, Georgia, Germany, Guatemala, Hong Kong, Hungary, India, Italy, Latvia, Mexico, Panama, Philippines, Romania, Saudi Arabia, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited
Outcome results
None listed