NL-OMON54333尚未招募2 期
A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors. - CABL001i12201
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 1
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
- •* Male or female participants:
- •a. Pediatric formulation group: >= 1 and less than 18 years of age at study
- •b. Adult formulation group: >= 14 and less than 18 years of age and body weight
- •of >= 40 kg at study entry.
- •* Participants with Ph+ CML-CP must meet all of the following laboratory values
- •at the screening visit. In the case where bone marrow blast and promyelocyte
- •counts are available, these will be accepted if done within 56 days prior to
- •the screening visit, to avoid unnecessary repetition of this test.
- •a. 15% blasts in peripheral blood and bone marrow
- •b. < 30% combined blasts plus promyelocytes in peripheral blood and bone marrow
- •c. < 20% basophils in the peripheral blood
- •d. Neutrophils >= 1.5 x 10^9/L (or white blood cell (WBC) >= 3 x 10^9/L if
- •neutrophils are not available) and platelet count >= 100 x 10^9/L
- •e. No evidence of extramedullary leukemic involvement, with the exception of
- •hepatosplenomegaly
- •* Prior treatment with a minimum of one TKI.
- •* Failure or intolerance to the most recent TKI therapy at the time of
- •* Evidence of typical BCR-ABL fusion gene (BCR-ABL1) transcript [e14a2 and/or
- •e13a2] at the time of screening which are amenable to standardized real time
- •quantitative polymerase chain reaction (RQPCR) quantification.
排除标准
- •* Known presence of the T315I mutation prior to study entry.
- •* Known second chronic phase of CML after previous progression to AP/BC.
- •* Previous treatment with a hematopoietic stem-cell transplantation.
- •* Patient planning to undergo allogeneic hematopoietic stem cell
- •transplantation.
- •* Cardiac or cardiac repolarization abnormality.
研究者
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