2024-511003-42-00招募中2 期
TAGVEN "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 Organization34 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年5月26日最近更新:
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
- 34
- 主要终点
- Proportion of participants who achieve a cCR after 3 TAGVEN cycles.
研究概览
简要总结
The primary objective is the efficacy of the tagraxofusp + venetoclax combination (TAGVEN) as measured by the rate of composite complete remission (cCR), defined as complete remission (CR) or complete remission with incomplete marrow recovery (Cri), according to the European Leukemia Net 2022 definitions for AML and adapted for BPDCN) or complete response with minimal residual skin abnormality (CRc[clinical]) defined by a marked clearance of ≥ 75% of a patient’s skin lesions from baseline and a complete metabolic response after 3 cycles of the combination of tagraxofusp and venetoclax in adult patients with a treatment-naive BPDCN.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •1.Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment ; 2.Age >18 years ; 3.Ability to understand the protocol and to sign an informed consent ; 4.Possibility of follow-up ; 5.ECOG < 3 ; 6.Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 45 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 ; 8.Albumin level≥3,2g/dL ; 9.Adequate liver function ; 10.Men, and women of childbearing potential must be using a highly effective method of contraception ; 11.Negative urine/blood pregnancy test within 1 week prior to the initiation of treatment
排除标准
- •Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment ; 2.Previous treatment with venetoclax or tagraxofusp ; 3.Concomitant immunosuppressive therapy –except for low-dose prednisone (≤10 mg/day) ; 4.Concomitant treatment with medications prohibited in association with venetoclax ; 5.Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients ; 6.Pregnant or breastfeeding woman ; 7.Peripheral neuropathy grade > 2 ;
- •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 ; 9.Known HIV-positivity ; 10.Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) ; 11.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 ; 12.Subject with a history of other malignancies prior to study ; 13.Malabsorption syndrome or other conditions that preclude enteral route of administration
结局指标
主要结局
Proportion of participants who achieve a cCR after 3 TAGVEN cycles.
Proportion of participants who achieve a cCR after 3 TAGVEN cycles.
次要结局
- - Objective response rate including cCR and partial remission after 3 TAGVEN cycles - Safety profile of the tagraxofusp and venetoclax combination - Proportion of patients with MRD - Negative responses measured by flow cytometry - Progression-free Survival - Duration of response - Overall Survival - Proportion of patients bridged to allogeneic stem cell transplantation - Possible predictors of response with respect to cytogenetics and mutational status
研究者
Dr David Ghez
Scientific
French Innovative Leukemia Organization
研究点 (34)
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