A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2026年4月27日最近更新: 2026年5月7日

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: M.D. Anderson Cancer Center
入组人数: 24
试验地点: 1
主要终点: Safety and adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.

详细描述

Primary Objectives

• To establish the minimum safe and biologically-effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy

Secondary Objectives

To determine the CR/CRi rate of the combination regimen
To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and clonoSEQ, relapse-free survival, overall survival, event-free survival)
To determine the safety of the combination regimen

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

•Diagnosis: Age ≥18 years with relapsed or refractory T-cell ALL.
•Performance status ≤2 (ECOG Scale).
•Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:
•Total serum bilirubin <2x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3 x ULN, unless due to the underlying leukemia approved by the PI
•Creatinine clearance ≥30 mL/min
•Ejection fraction ≥40%
•Ability to understand and the willingness to sign a written informed consent document
•Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study participation. For women of childbearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide.

排除标准

•Participant s who previously received lisaftoclax or any Bcl-xL inhibitor
•Active and uncontrolled infection
•Active secondary malignancy. Participant s with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI.
•Clinically significant, uncontrolled, active cardiovascular disease, including active grade III-V cardiac failure as defined by the New York Heart Association Criteria
•Prior investigational therapy within 14 days of enrollment, unless the participant has rapidly progressive disease judged to be life-threatening by the investigator. Cytoreduction with corticosteroids and/or hydroxyurea, is permitted.
•Recent exposure to strong inducer of CYP3A or p-glycoprotein within 14 days of study enrollment, or 5 half-lives, whichever is longer. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart
•Pregnant or lactating women
•Inability to swallow
•Unable or unwilling to sign the consent form
•Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection
•o Note: Participants who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Participants who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cytarabine, filgrastim, pegfilgrastim, lisaftoclax, and pelcitoclax or other agents used in study.
•Participants with psychiatric illness/social situations that would limit compliance with study requirements.