NL-OMON51567尚未招募3 期
A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302) - CABL001J12302
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 3
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
- 18 至 99（—）
入选标准
- •1. Males or females >= 18 years of age.
- •2. CML-CP within 3 months of diagnosis.
- •3. Diagnosis of CML-CP (European Leukemia Network 2020 criteria) with
- •cytogenetic confirmation of the Ph chromosome. Documented CML-CP will meet all
- •the criteria as mentioned in item 4 on page 10 of the protocol.
- •4. Evidence of typical BCR::ABL1 transcript. See item 5 on protocol page 10 for
- •5. ECOG performance status of 0 or 1.
- •6. Adequate end organ function as defined in item 7 on protocol page 10.
- •7. The laboratory values mentioned in item 8 on protocol pages 10/11 must be
- •within normal limits or must have been corrected to within normal limits with
- •supplements prior to randomization
排除标准
- •1. Previous treatment of CML with any other anticancer agents or prior stem
- •cell transplant, with the exception of hydroxyurea and/or anagrelide.
- •2. Known cytopathologically confirmed CNS infiltration.
- •3. Impaired cardiac function or cardiac repolarization abnormality. See item 3
- •on protocol page 11 for details.
- •4. Severe and/or uncontrolled concurrent medical disease that in the opinion of
- •the investigator could cause unacceptable safety risks or compromise compliance
- •with the protocol. See item 5 on protocol page 11 for examples.
- •5. History of significant bleeding disorder. See item 5 on protocol page 11 for
- •6. Major surgery within 4 weeks prior to study entry or not recovered from
- •prior surgery.
- •7. History of other active malignancy within 3 years prior to study entry. See
- •item 7 on protocol page 11 for exceptions.
- •8. History of acute pancreatitis within 1 year prior to randomization or
- •medical history of chronic pancreatitis.
- •9. History of chronic liver disease leading to severe hepatic impairment, or
- •ongoing acute liver disease.
- •10. Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV)
- •infection. See item 10 on protocol page 12 for details.
- •11. History of HIV unless well-controlled on a stable dose of anti-retroviral
- •therapy at the time of screening.
- •12. Impairment of GI function or GI disease that may significantly alter the
- •absorption of study treatment. See item 12 on protocol page 12 for details...
- •13. Participation in a prior investigational study within 30 days prior to
- •randomization or within 5 half-lives of the investigational product, whichever
- •14. Pregnant or lactating women
- •15. Women of child-bearing potential not using highly effective methods of
- •contraception. See item 15 on protocol page 12 for details.
研究者
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