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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044923

Enrollment

130

Registered

2022-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Dasatinib: Dasatinib at a dose of 70 mg once daily. Oral route of administration. Intervention period will be till progression or untoward side effect. Control Intervention1: Not applic

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
To determine the loss of molecular response.Timepoint: 2 years from the time of initiation	—

Secondary

Measure	Time frame
To study the toxicities of reduced dose Dasatinib. - To determine the 2-year molecular relapse free survival - To determine the 2-year Event free survival - To determine the 2-year overall survivalTimepoint: 2 years	—

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Centre

dr.hkjain@gmail.com02224177018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026