CTRI/2023/07/054825招募中2 期
Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia – A Phase 2 Study - NI
ady Tata Memorial Trust0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adults =18 - =65 years of age
- •2. Baseline diagnosis of T-ALL, including ETP-ALL
- •3. MRD positive (=0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1
- •4. CD38 positive (=20% blasts)
- •5. Eastern cooperative oncology group (ECOG) performance status =2
- •6. Acceptable liver functions, as specified below:
- •Total bilirubin <2 times upper limit of normal (ULN), Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) <3 ULN
- •7. Subject ready to sign an informed consent form
排除标准
- •1. T-LBL (T-lymphoblastic lymphoma) without BM involvement
- •2. Patients with central nervous system (positive CSF cytology at time of diagnosis of T-ALL) or testicular involvement
- •3. Patients with symptomatic obstructive airway disease, as per assessing clinician
- •4. Presence of an active systemic infection, as per assessing clinician
- •5. New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%
- •6. Human immunodeficiency virus (HIV) positive.
- •7. Pregnant or breastfeeding female
- •8. HBsAg positive or HBV-DNA positivity
研究者
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