A Phase II Study Using a BFM Regimen Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of complete molecular remission (CMR) at the end of one cycle of Dasatinib + BFM
研究概览
简要总结
This study will combine a standard, pediatric-inspired, chemotherapy regimen with the tyrosine kinase inhibitors (TKIs) Dasatinib and Ponatinib to treat adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
There are two age groups/cohorts:
- participants aged 18 to 59 years
- participants aged 60 years and older
One tyrosine kinase inhibitor (TKI), either Dasatinib or Ponatinib, will be administered in each of the respective chemotherapy cycles. The TKI (either Dasatinib or Ponatinib) administered in a given cycle of chemotherapy will be dictated by the given cycle's standard chemotherapy, in order to minimize overlapping side effects of the chemotherapy and TKI.
The dosages of the standard chemotherapy agents, as well as the tyrosine kinase inhibitors (TKIs)--Dasatinib and Ponatinib--have been adjusted for each age group to allow continuous administration of these TKIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BFM + Tyrosine Kinase Inhibitor
This study has 2 cohorts: participants aged 18 - 59 years and participants aged 60 or more years. Both cohorts receive the same study intervention with dosage adjusted for age. Participants receive the Berlin-Frankfurt-Münster (BFM) protocol plus dasatinib during a two-phase induction and a delayed re-induction. Participants receive the BFM protocol plus ponatinib during post-induction consolidations and maintenance.
干预措施: Dasatinib (Drug)
BFM + Tyrosine Kinase Inhibitor
This study has 2 cohorts: participants aged 18 - 59 years and participants aged 60 or more years. Both cohorts receive the same study intervention with dosage adjusted for age. Participants receive the Berlin-Frankfurt-Münster (BFM) protocol plus dasatinib during a two-phase induction and a delayed re-induction. Participants receive the BFM protocol plus ponatinib during post-induction consolidations and maintenance.
干预措施: Ponatinib (Drug)
BFM + Tyrosine Kinase Inhibitor
This study has 2 cohorts: participants aged 18 - 59 years and participants aged 60 or more years. Both cohorts receive the same study intervention with dosage adjusted for age. Participants receive the Berlin-Frankfurt-Münster (BFM) protocol plus dasatinib during a two-phase induction and a delayed re-induction. Participants receive the BFM protocol plus ponatinib during post-induction consolidations and maintenance.
干预措施: Berlin-Frankfurt-Münster Chemotherapy (Drug)
BFM + Tyrosine Kinase Inhibitor
This study has 2 cohorts: participants aged 18 - 59 years and participants aged 60 or more years. Both cohorts receive the same study intervention with dosage adjusted for age. Participants receive the Berlin-Frankfurt-Münster (BFM) protocol plus dasatinib during a two-phase induction and a delayed re-induction. Participants receive the BFM protocol plus ponatinib during post-induction consolidations and maintenance.
干预措施: Methotrexate and Cytarabine (Drug)
结局指标
主要结局
Rate of complete molecular remission (CMR) at the end of one cycle of Dasatinib + BFM
时间窗: Post day 36; up to day 43
CMR will be assessed by minimal residual disease (MRD)-negative status, using quantitative reverse transcription-polymerase chain reaction (RT-qPCR) analysis from bone marrow aspirates, after 1 cycle of induction therapy with Berlin-Frankfurt-Münster (BFM) protocol and Dasatinib.
次要结局
- Rate of Adverse Events related to Dasatinib and Ponatinib(30 days after last treatment, up to approximately 3 years)
- Complete cytogenic remission (CCyR) rate post induction(After Remission Induction Phase I and at end of study treatment, up to approximately 3 years)
- Complete molecular remission (CMR) rate(After Remission Induction Phase I and at end of study treatment, up to approximately 3 years)
- Disease-free survival (DFS)(up to five years after end of study treatment (approximately 8 years))
- Overall survival (OS).(up to five years after end of study treatment (approximately 8 years))
- Percentage of participants who begin ponatinib post-induction that complete at least one cycle.(At 18 weeks)
- Complete hematologic (morphologic) remission (CHR) rate after induction(After Remission Induction Phase I and at end of study treatment, up to approximately 3 years)