A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin's Lymphoma - A Phase 2b Randomized Study

TG THERAPEUTICS, INC.0 个研究点目标入组 735 人开始时间: 2021年2月2日最近更新: 2023年8月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: TG THERAPEUTICS, INC.
入组人数: 735

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Histologically confirmed diagnosis of: B-cell NHL with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues: a. Follicular Lymphoma (FL) of Grade 1, 2, or 3a; b. Small Lymphocytic Lymphoma (SLL); c. Marginal Zone Lymphoma (MZL) (splenic, nodal, or extranodal); or d. Diffuse Large B-Cell Lymphoma 2. Treatment status: a. FL/SLL patients: prior treatment with one or more lines of standard therapy b. MZL patients: prior treatment with one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after the most recent systemic treatment regimen; c. DLBCL patients: relapsed or refractory to any prior standard therapy AND who are non-candidates for high-dose therapy or autologous stem cell transplant. 3. Measurable disease, defined as at least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression. 4. Adequate organ system function, defined as follows: a. Absolute neutrophil count (ANC) > 1,000/mm3 (µL) & platelet count > 50,000/mm3 (µL) b. Total bilirubin =1.5 times the upper limit of normal (ULN) c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN if no liver involvement or =5 x the ULN if known liver involvement d. Calculated creatinine clearance >30 mL/min (as calculated by the Cockcroft-Gault formula) 5. ECOG performance status = 2 6. Male or female = 18 years of age 7. Ability to swallow and retain oral medication 8. Female patients who are not of child-bearing potential (see protocol Appendix B- Contraceptive Guidelines and Pregnancy), and female patients of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1. Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug. 9. Willingness and ability to comply with trial and follow-up procedures, and give written informed consent
•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 425
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 425

排除标准

•1. Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Day 1 of Cycle 1. a. Corticosteroid therapy started at least 7 days prior to study entry (prednisone =10 mg daily or equivalent) is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted. 2. Patients who have received autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded. 3. Evidence of chronic active Hepatitis B (HBV, not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody) or chronic active Hepatitis C infection (HCV), cytomegalovirus (CMV), or known history of HIV. If HBc antibody, HCV antibody or CMV is positive the subject must be evaluated for the presence of HBV, HCV, or CMV by DNA (PCR) - See protocol Appendix D. 4. Known history of Central Nervous System (CNS) lymphoma; patients with symptoms of CNS disease must have a negative CT scan and negative diagnostic lumbar puncture. 5. Known histological transformation from chronic lymphocytic leukemia to large cell lymphoma (i.e. Richter’s transformation) 6. Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails. 7. History of anaphylaxis (excluding infusion related reactions) in association with previous anti-CD20 administration. 8. Prior exposure to idelalisib (CAL-101), duvelisib (IPI-145), or any drug that specifically inhibits phosphoinositide-3-kinase (PI3K) 9. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a. Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV [see Appendix C – NYHA Classifications]) b. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization c. Concomitant use of medication known to cause QT prolongation or torsades de pointes. d. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of enrollment 10. Malignancy within 3 years of study enrollment except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer and PSA <1.0 mg/dL on 2 consecutive measurements at least 3 months apart with the most recent one being within 4 weeks of study entry

研究者

发起方

TG THERAPEUTICS, INC.

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