EUCTR2020-003695-40-IT进行中（未招募）1 期
A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6) - LOTIS 6
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Written informed consent must be obtained prior to any study procedures.
- •2. Male or female patients aged 18 years or older, with pathologic diagnosis of follicular lymphoma (Grade 1, 2, 3A) in the most recent tumor biopsy.
- •3. Relapsed or refractory disease following two or more treatment regimens, at least one of which must have contained an anti-CD20 therapy.
- •4.Patients who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19- directed therapy.
- •5. Measurable disease as defined by the 2014 Lugano Classification as assessed by positron emission tomography-computed tomography (PET CT) or, if not FDG-avid, CT or magnetic resonance imaging (MRI).
- •6. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
- •Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
- •7. ECOG performance status 0 to 2.
- •8. Adequate organ function as defined by screening laboratory values within the following parameters:
- •a. Absolute neutrophil count (ANC) =1.0 × 10^3/µL (off growth factors at least 72 hours),
- •b. Platelet count =75 × 10^3/µL without transfusion in the past 2 weeks,
- •c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) =2.5 × the upper limit of normal (ULN),
- •d. Total bilirubin =1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to =3×ULN).
- •e. Calculated creatinine clearance =30 mL/min by the Cockcroft and Gault equation.
- •Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility
- •9. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 6 months after the patient receives his last dose of study treatment.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. Previous treatment with loncastuximab tesirine.
- •2. Previous treatment with idelalisib.
- •3. Follicular lymphoma which has transformed to diffuse large B-cell
- •lymphoma (DLBCL) or other aggressive lymphoma.
- •4. Requires treatment or prophylaxis with a strong cytochrome P450
- •(CYP) 3A inhibitor, inducer, or sensitive substrate.
- •5. History of or ongoing drug-induced pneumonitis.
- •6. History of or ongoing inflammatory bowel disease.
- •7. Any condition that could interfere with the absorption or metabolism
- •of idelalisib including malabsorption syndrome, disease significantly
- •affecting gastrointestinal function, or resection of the stomach or small
- •8. Active second primary malignancy other than non-melanoma skin
- •cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or
- •lobular carcinoma in situ of the breast, or other malignancy that the
- •Sponsor's medical monitor and Investigator agree and document should
- •not be exclusionary.
- •9. Autologous transplant within 30 days prior to start of study treatment
- •10. Allogenic transplant within 60 days prior to start of study treatment
- •11. Active graft-versus-host disease.
- •12. Post-transplantation lymphoproliferative disorders.
- •13. Human immunodeficiency virus (HIV) seropositive with any of the
- •a. CD4+ T-cell counts <350 cells/µL.
- •b. Acquired immuno-deficiency syndrome (AIDS)-defining opportunistic
- •infection within 12 months prior to screening.
- •c. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4
- •weeks at the time of screening.
- •d. HIV viral load =400 copies/mL.
- •14. Serologic evidence of chronic hepatitis B infection and unable or
- •unwilling to receive standard prophylactic anti-viral therapy or with
- •detectable hepatitis B virus (HBV) viral load.
- •15. Serologic evidence of hepatitis C infection without completion of
- •curative treatment or with detectable hepatitis C virus (HCV) viral load.
- •16. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- •17. Lymphoma with active central nervous system involvement,
- •including leptomeningeal disease.
- •18. Clinically significant third space fluid accumulation (i.e., ascites
- •requiring drainage or pleural effusion that is either requiring drainage or
- •associated with shortness of breath).
- •19. Breastfeeding or pregnant.
- •20. Significant medical comorbidities, including but not limited to,
- •uncontrolled hypertension (BP =160/100 mm Hg repeatedly), unstable
- •angina, congestive heart failure (greater than New York Heart
- •Association class II), electrocardiographic evidence of acute ischemia,
- •coronary angioplasty or myocardial infarction within 6 months prior to
- •screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly
- •controlled diabetes, or severe chronic pulmonary disease.
- •21. Any Grade =3 active infection which requires IV antibiotics, IV
- •antiviral, or IV antifungal treatment.
- •22. Major surgery, radiotherapy, chemotherapy or other anti-neoplastic
- •therapy within 14 days prior to start of study treatment (C1D1), except
- 另有 9 项未显示
研究者
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