CTRI/2017/07/009035尚未招募3 期
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety and Immunogencity of SAIT101 Versus Rituximab as a first-line immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma
Archigen Biotech Limited21 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2017年7月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 试验地点
- 21
- 主要终点
- 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).
研究概览
简要总结
This is a multi-center,randomized, double-blind, parallel-group study to evaluate the efficacy and toassess the safety of SAIT101 versus MabThera in asymptomatic patients with lowtumor burden follicular lymphoma. This study will take place globally in orderto randomize approximately 308 participants. Eligible participants will berandomized to receive either SAIT101 or MabThera as an IV infusion once a weekfor 4 weeks at a standard dose of 375 mg/m2 body surface area. Patients will befollowed up for up to 52 weeks from the start of the first infusion, Efficacywill be assessed at Weeks 12 and 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged at least 18 years.
- •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 –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.
- •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)).
- •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.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Have at least one measurable lesion as per the IWG criteria 2007 at screening (lesion clearly measurable in at least 2 perpendicular dimensions).
- •Adequate renal function: Creatinine clearance 0.835 mL/s (50 mL/min) (Cockroft-Gault formula)
- •Adequate liver function: total bilirubin less than 34 μmol/L (2.0 mg/dL) except for patients with Gilbert’s Syndrome or hemolysis. Aspartate aminotransferase (AST) and alanineaminotransferase (ALT) less than 3 × upper limit of normal (ULN) (less than5 × 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 Gilbert’s Syndrome should have a direct bilirubin checked. If the direct bilirubin is normal and medical history is suggestive/positive for Gilbert’s Syndrome, the patient successfully meets the criteria.
- •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 contraception include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: Oral Intravaginal Transdermal •progestogen-only hormonal contraception associated with inhibition of ovulation 1: oral injectable implantable 2, intrauterine device (IUD) 2, Intrauterine hormone- releasing system IUS Bilateral tubal occlusion 2, vasectomised partner 2,3, sexual abstinence 4
- •Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraception method
- •Contraception methods that in the context of this guidance are considered to have low user dependency
- •Vasectomised partner is highly effective birth control method provided that partner is the sole sexual partner of the study participant and that the vasectomised partner has received medical assessment of the surgical success.
- •In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- •Female patients of childbearing potential must have a negative serum pregnancy test at screening visit 1 and a negative urine pregnancy test at each applicable visit thereafter. Females will be considered to be of non-childbearing potential if they fulfill one of the following criteria at screening:.
- •Postmenopausal defined as amenorrheic for at least 12 months following cessation of all exogenous treatments.
- •Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.
- •Able to provide written informed consent, which must be obtained prior to any study-related procedures.
排除标准
- •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 m
- •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.
- •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.
- •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.
- •Uncontrolled or severe hypertension, or verebrovascular disease.
- •Serious underlying medical conditions that per the investigators discretion could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, severe immunosuppression, uncontrolled diabetes mellitus, gastric ulcers, or active autoimmune disease).
- •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.
- •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.
- •Receipt of a live/attenuated vaccine within 6 weeks prior to the screening visit.
- •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.
结局指标
主要结局
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).
时间窗: Week 28
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28, as defined by International Working Group (IWG) criteria 2007.
时间窗: Week 28
This will be assessed centrally.
时间窗: Week 28
次要结局
- -Complete Response (CR)(-Partial Response (PR))
- 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)
- Overall response rate(Week 12)
研究者
研究点 (21)
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