Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients with Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL) - ISLAY

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 14 人开始时间: 2021年5月27日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•-Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy
•-Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration
•-Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue)
•-No more than 3 prior salvage therapies.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration
•- Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration
•- Clinical evidence of active central nervous system (CNS) leukemia
•- T-ALL with testicular involvement alone.

发起方

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT