JPRN-jRCTs041190043招募中2 期
A multicenter phase II study to evaluate a safety and efficacy of the clofarabine combination chemotherapy for infants with newly diagnosed MLL gene rearranged ALL and an exploratory study for infants with germline MLL gene ALL - MLL-17
Miyamura Takako0 个研究点目标入组 42 人开始时间: 2019年6月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
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
- ot applicable 至 <= 1age old（—）
- 性别
- All
入选标准
- •A patient must meet all of the following criteria in order to be eligible to participate in MLL-17 study:
- •(1) Infants less than 365 days of age at time of diagnosis of acute lymphoblastic leukemia (ALL)
- •(2) Patients with newly diagnosed ALL.
- •(3) A written informed consent of CHM-14 must be obtained prior to the registration of MLL-17.
- •(4) A written informed consent of MLL-17 registration must be obtained from the parents or guardians.
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in MLL-17 study:
- •(1) If patients are diagnosed at < 30 days of age, patients gestational age is less than 36 weeks and 0 days.
- •(2) If patients meet any of the following diagnostic criteria:
- •b. Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript,
- •c. Presence of t(8;14)(q24;q32), t(2;8)(p13;q24), t(8;22)(q24;q11) or specific fusion transcript associated with mature B-ALL
- •d.Down syndrome associated ALL
- •* Mixed phenotype acute leukemia (MPAL), and acute leukemia of ambiguous lineage (AUL) will be included in this clinical trial.
- •However, the following cases are excluded.
- •a. Cases in which the myeloblast ratio is higher than that of the lymphoblast
- •b. Cases which meet the criteria with T-ALL
- •c. Cases which meet the criteria with lymphoid antigen- positive AML
- •(3) Patients who evaluated as ECOG Performance status (PS) score 4 which modified for infants.
- •(4) Patients with unacceptable severe organ failure.
- •a. Patients with uncontrollable severe cardiac failure
- •b. Patients with uncontrollable severe renal failure
- •c. Patients with respiratory failure who require mechanical ventilation
- •d. Patients with unacceptable severe central nerve system hemorrhage
- •(5) Patients with uncontrollable severe infection.
- •(6) Patients with severe congenital disease or unacceptable complications.
- •(7) Patients with multiple primary cancer.
- •(8) Patients who received different chemotherapy or radiation therapy before registration.
- •(9) Patients who evaluated ineligible by principal physician.
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