Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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26 March 2024 |
Main ID: |
EUCTR2016-001966-27-HU |
Date of registration:
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21/07/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphoma
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Scientific title:
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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:
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07/09/2016 |
Target sample size:
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308 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001966-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belarus
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Bosnia and Herzegovina
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Bulgaria
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Chile
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Croatia
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Czech Republic
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Egypt
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France
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Georgia
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Germany
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Guatemala
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Hong Kong
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Hungary
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India
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Italy
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Korea, Republic of
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Latvia
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Mexico
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Panama
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Philippines
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Romania
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Saudi Arabia
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Serbia
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South Africa
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Spain
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Thailand
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Quintiles Call Center
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Address:
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Alba Campus, Rosebank
EH54 7EG
Livingston, West Lothian
United Kingdom |
Telephone:
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Email:
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QEudraCThelpdesk@quintilescontact.com |
Affiliation:
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Quintiles Ltd |
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Name:
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Quintiles Call Center
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Address:
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Alba Campus, Rosebank
EH54 7EG
Livingston, West Lothian
United Kingdom |
Telephone:
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Email:
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QEudraCThelpdesk@quintilescontact.com |
Affiliation:
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Quintiles Ltd |
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Key inclusion & exclusion criteria
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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 Association Class I
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Low Tumor Burden Follicular Lymphoma (LTBFL) MedDRA version: 20.0
Level: HLGT
Classification code 10025320
Term: Lymphomas non-Hodgkin's B-cell
System Organ Class: 10005329 - Blood and lymphatic system disorders
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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Timepoint(s) of evaluation of this end point: at Week 28 as defined by IWG criteria 2007
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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).
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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.
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Secondary Outcome(s)
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Secondary end point(s): Secondary Efficacy Endpoints: Tumor response evaluations as defined by the revised IWG Criteria 2007, for malignant lymphoma: ? Overall Response Rate (ORR) ? 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.
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Timepoint(s) of evaluation of this end point: For assessment of ORR + CR + PR + SD + PD = weeks 12 + 28 + unscheduled visits 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
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Source(s) of Monetary Support
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Archigen Biotech Limited
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Ethics review
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Status: Approved
Approval date: 22/08/2016
Contact:
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