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

Not yet recruiting

• Conditions: Acute lymphoblastic leukemia [ALL],

• Registration Number: CTRI/2022/08/044923
• Lead Sponsor: Tata Memorial Hospital Research Administrative Council

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-24
• Study Start: 2022-09-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

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.	2 years from the time of initiation

Secondary Outcome Measures

Name	Time	Method
To study the toxicities of reduced dose Dasatinib.	- To determine the 2-year molecular relapse free survival

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Hasmukh Jain

Principal investigator

02224177000

dr.hkjain@gmail.com