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

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2016-001966-27-ES
• Date of registration: 05/08/2016
• Prospective Registration: Yes
• Primary sponsor: Archigen Biotech Limited
• Public title: A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphoma
• Scientific title: 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
• Date of first enrolment: 23/09/2016
• Target sample size: 308
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001966-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Italy, Korea, Republic of, Latvia, Mexico, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sri Lanka, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Quintiles Call Center
• Affiliation: Quintiles Ltd

• Name: Quintiles Call Center
• Affiliation: Quintiles Ltd

Key inclusion & exclusion criteria

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. 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.
? 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 positive 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.
13. Central nervous system (CNS) or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma. A brain 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 Association Class III/IV; see Appendix 7), unstable angina, or uncontrolled cardiac arrhythmia.
16. Uncontrolled or severe hypertension, or cerebrov

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Low Tumor Burden Follicular Lymphoma (LTBFL)
MedDRA version: 19.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: SAIT101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: MabThera®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Primary Efficacy Endpoint:
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

Main Objective: To compare the efficacy of SAIT101 with rituximab (MabThera®) 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:
• Safety and tolerability;
• Immunogenicity;
• Pharmacokinetics (PK) and pharmacodynamics (PD) in a sub population of patients.

Secondary Outcome(s)

Secondary end point(s): Secondary Efficacy Endpoints:
Tumor response evaluations as defined by the revised IWG Criteria 2007, for malignant lymphoma:
? Complete Response (CR)
? Partial Response (PR)
? Stable Disease (SD)
? Progressive disease (PD)
? Time to event (TTE), defined as the time from the date of randomization to the date when an event occurs; an event is disease progression, death due to any cause, or the start of new treatment for FL, whichever comes first
drug concentration,
CD19 + B-cell count and
immunogenicity.

Timepoint(s) of evaluation of this end point: For assessment of CR + PR + SD + PD = week 28 as per table 1 (CT scan)
For TTE, it is at any time or visits (from weeks 1/2/3/4/5/12/20/28/36/52) or at any unscheduled visit
For drug concentration (PK) = weeks 1/2/3/4/5/12/20/28
For CD19 + B-cell count (hematology) = weeks 1/2/3/4/5/12/20/28/36/52 + unscheduled visit
For immunogenicity = weeks 1/2/3/4/5/12/20/28/36/52 + unscheduled visit

Secondary ID(s)

AGB002

2016-001966-27-HU

Source(s) of Monetary Support

Archigen Biotech Limited

Ethics review

Status: Approved
Approval date: 20/09/2016
Contact:

Results

• Results available: Yes
• Date Posted: 29/08/2020
• Date Completed: 10/01/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001966-27/results