NCT07007052招募中2 期
Open Label Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients
French Innovative Leukemia Organisation68 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年12月11日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 68
- 主要终点
- Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles
研究概览
简要总结
The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients.
The main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment.
Patients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment : patients with skin or lymph node lesions but no bone marrow involvement can be included
- •Age >18 years
- •Ability to understand the protocol and to sign an informed consent
- •Possibility of follow-up
- •Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault formula.
- •Adequate cardiac function defined by LVEF >/= 50% by MUGA or ECHO and no clinically significant abnormalities on a 12-lead ECG
- •Albumin level≥3,2g/dL
- •Adequate liver function as demonstrated by:
- •aspartate aminotransferase (AST) ≤ 2.5 × ULN*
- •alanine aminotransferase (ALT) ≤ 2.5 × ULN*
- •bilirubin ≤ 3.0 × ULN, unless due to Gilbert's syndrome* * Unless considered due to leukemic organ involvement, in that cases values must be ≤ 10 × ULN
- •Men, and women of childbearing potential must be using a highly effective method of contraception
- •Negative urine/blood pregnancy test within 1 week prior to the initiation of treatment (if applicable)
- •Patient covered by any social security system
排除标准
- •Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.
- •Previous treatment with venetoclax or tagraxofusp
- •Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion
- •Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg/day)
- •Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients.
- •Pregnant or breastfeeding woman
- •Known positivity for hepatitis B or C infection except for those subjects with an undetectable viral load or subjects with serologic evidence of prior vaccination to HBV
- •Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal)
- •Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
- •Cardiovascular disease e.g., NYHA heart failure > class 2, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrythmias not controlled by medication.
- •Renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
- •Subject with a history of other malignancies within the last three years prior to study entry, except for:
- •Adequately treated in situ carcinoma of the breast or cervix uteri
- •Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
- •Prostate cancer without needs for specific therapy
- •Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- •Malabsorption syndrome or other conditions that preclude enteral route of administration
- •Patient with hereditary fructose intolerance
研究组 & 干预措施
Single interventional arm
Experimental
For each 28 days-cycle of treatment :
- venetoclax 400mg/day orally after a ramp-up period of 3-days
- tagraxofusp starting at the end of the venetoclax ramp-up period i.e. at day 4 for twelve 28-days cycles, 12 μg/kg body weight administered as an intravenous infusion over 15 minutes, once daily, on days 1-3 of each cycle
干预措施: Venetoclax (Drug)
Single interventional arm
Experimental
For each 28 days-cycle of treatment :
- venetoclax 400mg/day orally after a ramp-up period of 3-days
- tagraxofusp starting at the end of the venetoclax ramp-up period i.e. at day 4 for twelve 28-days cycles, 12 μg/kg body weight administered as an intravenous infusion over 15 minutes, once daily, on days 1-3 of each cycle
干预措施: Tagraxofusp (Drug)
结局指标
主要结局
Proportion of participants who achieve a cCR (CR or Cri or CRc) after 3 TAGVEN cycles
时间窗: From enrollment to the end of the third 28 days-cycle
Evaluation will be done with a bone marrow aspirate, cytogenetics, metabolic imaging, study of MRD by NGS and flow-cytometry and SWAT SCORE
次要结局
未报告次要终点
研究者
研究点 (68)
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