NL-OMON53624尚未招募2 期
A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA - InO Monotherapy vs ALLR3 as Induction Treatment of childhood A
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 4
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
- 年龄范围
- 0 至 17（—）
入选标准
- •Participants must meet the following key inclusion criteria to be eligible for
- •enrollment into the study:
- •1. Male or female participants between 1 and <18 years of age.
- •2. Morphologically confirmed diagnosis of first relapse HR BCP ALL:
- •CD22-positive ALL as defined by local institution.
- •Bone marrow involvement of >= 5% leukemic blasts (>= M2 status).
- •3. Cardiac shortening fraction >= 30% by echocardiogram or ejection fraction >
- •50% by MUGA.
排除标准
- •Participants with any of the following key characteristics/conditions will be
- •1. Any history of prior or ongoing hepatic SOS or prior liver failure [defined
- •as severe acute liver injury with encephalopathy and impaired synthetic
- •function (INR of >=1.5)].
- •2. Prior allo-HSCT or CAR T-cell therapy.
- •3. Isolated extramedullary leukemia.
- •4. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present.
- •5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or
- •gemtuzumab ozogamicin).
- •6. Participants with active, uncontrolled bacterial, fungal, or viral
研究者
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