KCT0007113招募中未知
Phase II study of Glofitamab, Poseltinib and Lenalidomide in patients with relapsed/refractory diffuse large B cell lymphoma
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Men and women 19 years of age and older
- •2. Histologically diagnosed B-cell Non-Hodgkin's Lymphoma, which is expected to express CD20
- •-Diffuse large B-cell lymphoma(DLBCL)
- •-(Transformed follicular lymphoma)
- •3. Patients whose previous treatment failed or relapsed after the previous treatment, and the last medication was 2 weeks or more before the registration.
- •-Must have previously received anti-CD20-based treatment.
- •-If the patient is a candidate for autologous hematopoietic stem cell transplantation, at least two therapies have failed.
- •-If the patient is not suitable for autologous hematopoietic stem cell transplantation, at least one therapy has failed.
- •4. If the patient's immunohistochemistry result is BCL6(-) and MYC(+), it is not suitable
- •5. Two-dimensionally measurable nodal lesion with the longest length of 1.5 cm at least one or more, or two-dimensionally measurable extranodal lesion with the longest length of 1.0 cm at least one or more
- •6. Eastern Cooperative Oncology Group is 0,1 or 2
- •7. Adequate liver function, kidney function, hematopoietic function
- •-Total bilirubin = 2 x ULN or AST, ALT = 3 x ULN
- •-WBC = 3,000 /µL, ANC = 1,000 /µL, Platelets = 75,000 /µL, or Hemoglobin = 9.0 g/dL
- •-Correction by blood transfusion within 2 weeks is not permitted
- •-Cr = 1.5 x ULN and CLcr = 30 mL/min/1.73m2
- •8. Hepatitis B virus (HBV) infection was negative (hepatitis B surface antigen (HBsAg) negative). In case of latent HBV infection or previous infection (HBsAg negative and hepatitis B core antibody (HBcAb) positive), HBV DNA is not detected. The patient is willing to undergo DNA testing and appropriate antiviral therapy on Day 1 of each cycle and every 3 months for 12 months after the last cycle.
- •9. Hepatitis C virus, HCV is negative.
- •10. Human immunodeficiency virus, HIV is negative.
- •11. Sexually active women of childbearing potential should have two negative urine hCG tests prior to administration of the test drug.
- •During the first month of the study, a weekly urine test was performed. After that, a urine test should be performed every 4 weeks or every 2 weeks if menstruation is irregular.
- •Urine hCG testing should be performed until 4 weeks after the last administration of glofitamab, poseltinib, and lenalidomide.
- •Women of childbearing potential should use two methods of contraception, including at least one highly effective method of contraception 4 weeks before the first treatment, during the treatment period, 4 weeks after the last dose of poseltinib or lenalidomide, 2 months after the last dose of glofitamab, and until 18 months after the last dose of obinutuzumab.
- •Pregnancy testing is not required for women who are unable to conceive after menopause (at least 12 months of drug-related amenorrhea) or surgically (no ovaries or uterus or both).
- •Sexually active men should use condoms during treatment and until 4 weeks after the last dose of poseltinib or lenalidomide, 2 months after the last dose of glofitamab, and 3 months after the last dose of obinutuzumab.
- •12. Subjects must be able and willing to participate in all necessary evaluations and procedures of the study protocol, and be able to swallow oral medications without difficulty.
- •13. Subjects must understand the purpose and risks of the study and be able to authorize the use of their medical information for the purpose of the study.
排除标准
- •1. Patients who have previously received 4 or more chemotherapy
- •2. Patients with or with a history of macrophage activation syndrome/hemophagocytic lymphohistiocytosis (MAS/HLH).
- •3. Patients who have previously received Glofitamab.
- •4. A patient with acute bacterial, viral, or fungal infection, confirmed with a positive blood culture test or if there is no positive blood culture test, it is diagnosed by clinical judgment.
- •5. Patients with a known active infection or reactivation of a latent infection, regardless of bacterial, viral, fungal, mycobacterial or other pathogen or patients with major infection episodes requiring hospitalization or intravenous antibiotic treatment within 4 weeks of administration
- •6. Patients who have previously received systemic immunotherapy, radioimmunoconjugates, antibody-drug conjugates, immune checkpoint inhibitors (eg. anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), Patients who received anti-programmed death 1 (anti-PD1) and anti-programmed death ligand 1 (anti-PDL1) drugs within 4 weeks before administration of the test drug or within 5 half-lives of the drug.
- •7. Patients with a treatment-emergent immune-related AE when using previous immunotherapy
- •8. Patients who received radiation therapy, chemotherapy, or other experimental chemotherapy, including chimeric antigen receptor therapy (CAR-T), within 4 weeks of the first dose of study drug.
- •9. Patients who have received an allogeneic hematopoietic stem cell transplant within 1 year or have previously received a solid organ transplant.
- •10. Patients who received autologous hematopoietic stem cell transplantation within 100 days of the first dose of the study drug
- •11. Patients with graft-versus-host disease (GVHD) requiring treatment
- •12. Patients unable to take oral medications
- •13. Patients resistant to BTK inhibitor or lenalidomide (defined as PFS of less than 6 months to BTK inhibitor and lenalidomide)
- •14. If you have been diagnosed with a malignant disease other than cancer included in this study in the past, provided that basal cell carcinoma, squamous cell skin cancer, and in situ cancer that have been properly treated , and cancers with no disease for more than 5 years are excluded from other malignant diseases.
- •15. Patients with clinically significant cardiovascular disease, with heart disease corresponding to New York Heart Association Functional Class III or IV or Objective class C or D, myocardial infarction within 6 months, uncontrolled arrhythmia or unstable angina patient.
- •However, patients with well-controlled and asymptomatic atrial fibrillation may be enrolled.
- •16.malabsorption syndrome, diseases that significantly affect the functioning of the gastrointestinal tract; resection of the stomach or small intestine that may affect absorption; symptomatic inflammatory bowel disease, partial or complete intestinal obstruction; Bariatric surgery, such as gastric restriction and gastric bypass surgery
- •17.Patients with a history of drug-specific hypersensitivity or anaphylaxis to the test drug (including active ingredients or excipients)
- •18.Disease with or possibly bleeding uncontrolled, active bleeding (such as hemophilia or von Willebrand disease)
- •19. Autoimmune hemolytic anemia, AIHA or Idiopathic thrombocytopenic purpura (ITP)
- •20.Patients requiring treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors/inducers
- •21.Patients who need or are taking warfarin or an equivalent vitamin K antagonist (eg phenproc
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