CTRI/2017/12/010783进行中（未招募）2 期
SADAL: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •To be included in this study, a patient must meet all the following criteria:
- •1. Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screeningprocedure.
- •2. Age >=18 years
- •3. ECOG performance status of <= 2.
- •4. Patients should have estimated life expectancy of >3 months at study entry.
- •5. Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
- •6. Patients must have received at least 2 but no more than 5 previous systemic regimens
- •for the treatment of their de novo or transformed DLBCL including (i) at least
- •1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Patients who were considered ineligible for standard multi-agent
- •immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
- •7. For patients whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other patients, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered
- •anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
- •8. Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
- •9. Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014). Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes <= 1.0 by <= 1.0 will not be considered abnormal for relapse or PD.
- •10. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male patients must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose (see Section 13.5.2.1 Permitted Concomitant Medication â?? Prevention of Pregnancy for description of acceptable contraceptive methods).
排除标准
- •Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.
- •1. Patients who are pregnant or lactating
- •2. DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma (Hodgkinâ??s lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL.
- •3. Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
- •4. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility)
- •5. Known central nervous system lymphoma or meningeal involvement
- •6. For patients whose most recent systemic anti DLBCL therapy induced a PR or CR Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids more than 60 days prior to Cycle 1 Day 1
- •7. For patients whose most recent systemic anti-DLBCL therapy did not induce a PR or CR Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids more than 14 weeks prior to Cycle 1 Day 1
- •8. Patients who have not recovered to Grade more than or equal to 1 clinically significant AEs, or to their baseline, from their most recent systemic anti-DLBCL therapy
- •9. Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation
- •10. Major surgery within 2 weeks of first dose of study treatment
- •11. Any life threatening illness, medical condition or organ system dysfunction which, in the Investigator opinion, could compromise the patientâ??s safety
- •12. Unstable cardiovascular function:
- •a. Symptomatic ischemia, or
- •b. Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or
- •c. Congestive heart failure of New York Heart Association Class more than or equal to 3, or
- •d. Myocardial infarction within 3 months
- •13. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose however, prophylactic use of these agents is acceptable even if parenteral
- •14. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •15. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study)
- •16. Patients unable to swallow tablets, patients with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment
- •17. Any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) less than 1000 cells/mm3 or platelet count less than 75,000/mm3 during screening and on C1D1. Use of granulocyte-stimulating factors and platelet growth factors prior to and during the study is acceptable
- •b. A circulating lymphocyte count of more than 50,000/μL.
- •c. Hepatic dysfunction: bilirubin more than 2.0 times the upper limit of normal (ULN) (except patients with Gilbertâ??s syndrome: total bilirubin of more than 3 x ULN) and alanine aminotransferase (ALT) and aspartate aminotra
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