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

Tata Memorial Hospital Research Administrative Council0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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

•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)

发起方

Tata Memorial Hospital Research Administrative Council