NCT07621406进行中（未招募）2 期
Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma, Prospective Phase II Clinical Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the efficacy and safety of tafasitamab combined with lenalidomide plus standard immunochemotherapy, followed by sequential autologous stem cell transplantation (ASCT), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Pathologically confirmed diagnosis of relapsed or refractory DLBCL;
- •Patients must meet the following criteria:
- •Definition of relapsed or refractory: Refractory: Patients who did not achieve remission (≥PR) with the most recent systemic therapy; Relapsed/progressive: Patients who developed new lesions or experienced a ≥50% increase in existing lesions (based on the Lugano 2014 classification for non-Hodgkin lymphoma) following the most recent systemic therapy;
- •At least one bidimensionally measurable lesion, defined as a lesion with the longest dimension >1.5 cm and perpendicular diameter >1.0 cm on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI), confirmed as positive by PET-CT;
- •For DLBCL, prior receipt of at least one line but no more than four lines of systemic therapy, which must include CD20-targeted therapy;
- •ECOG performance status score of 0-
- •Meet the criteria for autologous hematopoietic stem cell transplantation (ASCT) and be willing to undergo ASCT;
- •Adequate major organ function:
- •Liver function: ALT/AST <3× upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L;
- •Renal function: Creatinine <220 μmol/L;
- •Pulmonary function: Oxygen saturation ≥95% without supplemental oxygen;
- •Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%;
- •Transplant comorbidity index score ≤
- •As judged by the investigator, patients must:
- •Be willing to receive adequate prophylaxis and/or treatment for thromboembolic events;
- •Be able to understand and sign informed consent, and comply with all study-related procedures, medication use, and evaluations;
- •Have no history of non-adherence to medical prescriptions or be deemed by the investigator to have no potential for non-adherence;
- •Be able to understand and comply with pregnancy prevention requirements and reasons, the pregnancy prevention risk management plan, and provide written confirmation.
排除标准
- •Pregnant (positive urine/serum pregnancy test) or lactating women;
- •Men or women with plans for conception within 1 year;
- •Inability to guarantee effective contraceptive measures (e.g., condoms, contraceptives) within 1 year after enrollment;
- •Uncontrolled infectious disease within 4 weeks prior to enrollment;
- •Active hepatitis B or C virus infection;
- •Severe autoimmune disease or immunodeficiency disorder;
- •History of allergy to macromolecular biologic drugs such as antibodies or cytokines;
- •Participation in another clinical trial within 6 weeks prior to enrollment;
- •Systemic use of corticosteroids within 4 weeks prior to enrollment (excluding patients using inhaled corticosteroids);
- •Psychiatric illness;
- •Substance abuse/dependence;
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Trial of a novel agent in participants with previously treated Immunoglobulin Light-Chain (AL) Amyloidosis2024-519191-90-00European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale24
招募中
2 期
A trial for relapsed Multiple Myeloma patients (Isatuximab-dexamethasone)2024-513397-21-00Emn Trial Office S.r.l. Impresa Sociale25
尚未招募
3 期
Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.Chronic Idiopathic UrticariaNCT07486583Cairo University40
招募中
2 期
MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological DiseasesAMLMyelodysplastic SyndromesMDSAcute Myeloid LeukemiaAcute LeukemiaNCT07493538Masonic Cancer Center, University of Minnesota132
进行中（未招募）
3 期
RAM-MSMultiple sclerosis2024-510630-40-00Helse Bergen HF100