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CTRI Number  CTRI/2022/08/044923 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 24/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   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 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  Room No 81, Adult Hematolymphoid Unit Main Building, Ground Floor, Tata Memorial Hospital Dr E Borges Road, Parel, Mumbai, MAHARASHTRA-400012, India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  Room No 81, Adult Hematolymphoid Unit Main Building, Ground Floor, Tata Memorial Hospital Dr E Borges Road, Parel, Mumbai, MAHARASHTRA-400012, India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  Room No 81, Adult Hematolymphoid Unit Main Building, Ground Floor, Tata Memorial Hospital Dr E Borges Road, Parel, Mumbai, MAHARASHTRA-400012, India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Research Administrative Council  
 
Primary Sponsor  
Name  Tata Memorial Hospital Research Administrative Council  
Address  Tata Memorial Hospital Research Administrative Council Clinical Research Secretariat 3rd Floor, Main Building Tata Memorial Hospital Dr E Borges Road Parel Mumbai-400012 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasmukh Jain  Tata Memorial Centre  OPD no-81, Main Building, Ground Floor, Tata Memorial Hospital,Dr. E. Borges Road Parel- 400012 Mumbai
Mumbai
MAHARASHTRA 		 02224177000

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-1, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dasatinib  Dasatinib at a dose of 70 mg once daily. Oral route of administration. Intervention period will be till progression or untoward side effect. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the loss of molecular response.   2 years from the time of initiation 
 
Secondary Outcome  
Outcome  TimePoints 
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 survival 		 2 years 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 “Dasatinib”. 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 
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