A single-arm phase II study (DASLOW) to evaluate the ability to maintain molecular response with Reduced dose Dasatinib(70 mg once daily) in patients with De-Novo Philadelphia positive Acute Lymphoblastic Leukemia (Ph positive ALL) after achieving deep molecular response during the intensive phase of treatment
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To determine the loss of molecular response.
研究概览
简要总结
Acute Lymphoblastic Leukaemia[ALL] is a type of blood cancer. Ph positive ALL is a subtype of ALL most commonly found in adult patients(25%). These patients are treated with chemotherapy combined with a drug called “Dasatinibâ€. While chemotherapy is given for 6-8 months, Dasatinib is given lifelong. Dasatinib is a targeted therapy medication used to treat certain cases of chronic myelogenous leukemia and acute lymphoblastic leukemia. Specifically it is used to treat cases that are Philadelphia chromosome-positive patients. Dasatinib is given with the conventional cytotoxic chemotherapy drugs in order to increase the rate of response The problem of using Dasatinib at a dose of 100-140 mg is that it leads to side effects over a period of time and which leads to treatment interruption. Therefore, in our study we propose to develop a strategy wherein, the dose of Dasatinib would be reduced to 70 mg once daily after completion of intensive phase and once patients achieve a deep response, we intend to determine the proportion of patients who lose the molecular response after initiation of Reduced dose Dasatinib over a follow-up period of 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Philadelphia positive Precursor B-cell ALL determined by either identification of t (9;22) karyotype or BCR-ABL fusion transcript.
- •b) Completed the intensive phase of treatment (Standard dose Dasatinib(100-140 mg once daily) positive/negative Chemotherapy (As per modified BFM90 protocol or adult ALL protocols)) c) Having sustained molecular response as defined as BCR/ABL transcript ratio of less than 0.01% on at least two different occasions.
- •d) Age 15 years and less than 45 years e) Performance status (ECOG)0-3 f) Adequate liver function tests (Bilirubin less than 2X ULN, SGOT/PT less than 5 times ULN) and renal function tests (creatinine less than 2X ULN) (unless due to leukemia at the discretion of investigator) g) Adequate cardiac function- LVEF- greater than 45 percent h) Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals i) Signed informed consent.
排除标准
- •Active serious infection not controlled by oral or intravenous antibiotics b) Active grade III-IV cardiac failure as defined by New York Heart Association criteria c) Dose reduction of Dasatinib to less than 70 mg during the intensive phase d) Pregnant and lactating women e) Women of child bearing age group should have a negative pregnancy test(either urine pregnancy test or beta HCG) f) Subject has a history of malignancy within 3 years before the date of enrolment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 3 years).
结局指标
主要结局
To determine the loss of molecular response.
时间窗: 2 years from the time of initiation
次要结局
- To study the toxicities of reduced dose Dasatinib.(- To determine the 2-year molecular relapse free survival)