EUCTR2018-001843-29-GB进行中（未招募）1 期
TASTER- TArgeting STEm cell Resistance An umbrella adaptive randomised multi–arm screening phase II trial for patients with 2nd/3rd generation TKI resistant chronic myeloid leukaemia - TASTER -TArgeting STEm cell Resistance
HS Greater Glasgow and Clyde0 个研究点目标入组 102 人开始时间: 2019年11月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •There are separate inclusion criteria's for each phase of disease. The principal inclusion criteria are noted below:
- •Chronic Phase
- •1.Patient aged >18 years.
- •2.Patient has given written informed consent to participate in the trial.
- •3.Patients with Ph+, BCR ABL + Chronic Phase CML.
- •4.Prior treatment with at least two 2nd (nilotinib, dasatinib or bosutinib) or 3rd generation (ponatinib) TKI, or imatinib after failure or intolerance to 2nd/3rd generation TKI, on stable TKI for period of > 6 months.
- •5.No switch between TKIs within the last 6 months.
- •6.ELN failure defined as BCR-ABL level on IS of >10% and/or Ph >35% at > 6 months of taking 2nd/3rd generation TKI or >1% and/or Ph >0% by 12 months of taking 2nd/3rd generation TKI. Patients entering TASTER on imatinib need to meet the above definition for failure of 2nd/3rd generation TKI and/or be intolerant to 2nd/3rd generation TKI, and have ELN failure on imatinib.
- •7.Patients with ECOG grade 0 to 2.
- •8.Patients require to have adequate renal function defined as calculated creatinine clearance > 40ml/min.
- •9.Adequate haematological and biochemical function
- •10.Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures.
- •11.Ability to swallow oral medications
- •12.Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation and agree to use highly effective contraceptive measures from the time of negative pregnancy test up to 90 days after the last dose of study drug.
- •13.Male patients with partners of child-bearing potential must agree to use highly effective contraceptive measures for the duration of the study and up to 90 days after the last dose of study drug.
- •Accelerated Phase
- •1.Patient aged >18 years.
- •2.Patient has given written informed consent to participate in the trial.
- •3.Patients with Ph+, BCR-ABL + Accelerated Phase CML defined as presence of one of the following:
- •Blasts in blood or marrow 15-29%, or blasts plus promyelocytes in blood or
- •marrow >30%, with blasts <30%
- •Basophils in blood =20%
- •Persistent thrombocytopenia (<100x109/L) unrelated to therapy
- •Clonal chromosome abnormalities in Ph+ cells (CCA/Ph+), major route, on
- •4.Treatment with > one 2nd (nilotinib, dasatinib or bosutinib) or 3rd generation (ponatinib) TKI, or imatinib after failure or intolerance to 2nd/3rd generation TKI, on stable TKI for period of > 3 months.
- •5.No switch between TKIs within the last 3 months.
- •6.Failure in accelerated phase defined as BCR-ABL level on IS of >10% and/or Ph>65% at 3 months, >10% or Ph >35% at > 6 months or >1% and/or Ph >0% by 12 months of taking 2nd/3rd generation TKI. Patients entering TASTER on imatinib need to meet the above definition for failure of 2nd/3rd generation TKI and/or be intolerant to 2nd/3rd generation TKI, and have ELN failure on imatinib
- •7.Patients with ECOG grade 0 to 2.
- •8.Patients require to have adequate renal function defined as calculated creatinine clearance > 40ml/min.
- •9.Adequate haematological and biochemical function
- •10.Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures.
- •11.Ability to swallow oral medications
- •12.Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation and agree to use highly effective contraceptive measures from the time of negative pregnancy test up to 90 days after the last dose of study drug.
- •13.Male patients with partner
排除标准
- •There are separate exclusion criteria's for each phase of disease. The principal exclusion criteria are noted below:
- •Chronic Phase
- •1.Pregnant or lactating women.
- •2.Females of child bearing potential or males not willing to use a highly effective method of contraception.
- •3.Patient in planning for allogeneic SCT within 6 months.
- •4.Patients with cardiovascular disease defined as:
- •QTc > 450 (males), 470 (females);
- •Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure within the previous 6 months;
- •Myocardial infarction within the previous 6 months;
- •Symptomatic cardiac arrhythmia requiring treatment within the previous 6 months;
- •Grade III or IV fluid retention within the previous 6 months.
- •5.Known BCR-ABL kinase domain mutation expected to be sensitive to an alternative TKI.
- •6.Patients with a history of another malignancy other than non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix; the exception is if patients have been disease-free for at least 5 years, and are deemed by the investigator to be low risk for recurrence of that malignancy.
- •7.Patients with history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute lymphoblastic leukaemia (T –ALL).
- •8.Patients with thrombocytopenia, neutropenia or anaemia of grade > 3 (per CTCAE version 5.0 criteria) or any prior history of other myeloid malignancies including myelodysplastic syndrome (MDS).
- •9.Patients taking medications that are known strong CYP3A4 inducers and inhibitors (including St. John’s Wort) unless stopped at least 14 days before commencing trial medication.
- •10.Patients unwilling to remove Seville oranges, grapefruit juice and grapefruits from their diet.
- •Accelerated Phase Patients
- •Exclusion Criteria – Accelerated Phase Patients
- •1.Pregnant or lactating women.
- •2.Females of child bearing potential or males not willing to use a highly effective method of contraception.
- •3.Patient in planning for allogeneic SCT within 6 months.
- •4.Patients with cardiovascular disease defined as:
- •QTc > 450 (males), 470 (females);
- •Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure within the previous 6 months;
- •Myocardial infarction within the previous 6 months;
- •Symptomatic cardiac arrhythmia requiring treatment within the previous 6 months;
- •Grade III or IV fluid retention within the previous 6 months.
- •5.Known BCR-ABL kinase domain mutation expected to be sensitive to an alternative TKI.
- •6.Patients with a history of another malignancy other than non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix; the exception is if patients have been disease-free for at least 5 years, and are deemed by the investigator to be low risk for recurrence of that malignancy.
- •7.Patients with history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute lymphoblastic leukaemia (T –ALL).
- •8.Patients with thrombocytopenia, neutropenia or anaemia of grade > 3 (per CTCAE version 5.0 criteria) or any prior history of other myeloid malignancies including myelodysplastic syndrome (MDS).
- •9.Patients taking medications that are known strong CYP3A4 inducers and inhibitors (including St. Johns Wort) unless stopped at least 14 days before commencing trial medication
- •10.Patients unwilling to remove Seville oranges, grapefruit juice and grapefruits from thei
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