A research to understand the use of low dose Dasitinib in a type of blood cancer where initial treatment of 6-8 months has been completed

Phase 2

Conditions: Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Registration Number: CTRI/2022/08/044923

Lead Sponsor: Tata Memorial Hospital Research Administrative Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the loss of molecular response.Timepoint: 2 years from the time of initiation

Secondary Outcome Measures

Name	Time	Method
To study the toxicities of reduced dose Dasatinib. <br/ ><br>- To determine the 2-year molecular relapse free survival <br/ ><br>- To determine the 2-year Event free survival <br/ ><br>- To determine the 2-year overall survivalTimepoint: 2 years