FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077421 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Studying How Many CML Patients remain Healthy One Year After Stopping Imatinib Treatment 
Scientific Title of Study   Treatment-free remission in chronic myeloid leukemia 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sachin Punatar 
Designation  Professor and Medical Oncologist  
Affiliation  Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre  
Address  Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9833445041  
Fax    
Email  drsachin_punatar@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Punatar 
Designation  Professor and Medical Oncologist  
Affiliation  Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre  
Address  Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9833445041  
Fax    
Email  drsachin_punatar@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Sachin Punatar 
Designation  Professor and Medical Oncologist  
Affiliation  Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre  
Address  Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9833445041  
Fax    
Email  drsachin_punatar@yahoo.in  
 
Source of Monetary or Material Support  
Max Foundation NE 45th Street, suite 230 Seattle WA 98105 USA  
 
Primary Sponsor  
Name  ACTREC, Tata Memorial Centre 
Address  Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai Maharashtra India. 
Type of Sponsor  Research institution and hospital 
 
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 Sachin Punatar  ACTREC-Tata Memorial Centre   Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan Building sector 22 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA 		 09833445041

drsachin_punatar@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C921||Chronic myeloid leukemia, BCR/ABL-positive,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patient should be currently enrolled in the Max Access Solution (MAS) program of the Max Foundation. (This program was previously known as the GIPAP (Global International Patient Access Program). Under this program, enrolled patients are already receiving imatinib from the Max Foundation.)
2.Chronic phase CML (CML-CP)
3.On imatinib for more than 10 years
4.No history of imatinib resistance
5.RQ-PCR IS value less than 0.0032% for a minimum of 12 months (confirmed at least twice)
 
 
ExclusionCriteria 
Details  1.Patients with accelerated phase or blast crisis at any point of time in the past
2.Patients not willing to sign the informed consent form /personal data notice.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to determine the proportion of patients who will continue to remain in major molecular response (MMR) at 1 year (+/- 1 month) of discontinuation of imatinib.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the kinetics of RQ-PCR for BCR-ABL in patients under TFR
2.To determine the incidence of “imatinib withdrawal”. (Imatinib withdrawal refers to a symptom complex which occurs due to sudden discontinuation of imatinib. The manifestations typically include bodyache, mild joint pains and occasionally low-grade fever).
3.In the event of TFR failure, to determine the proportion of patients who regain MMR after restarting imatinib. (TFR failure is defined below)
 		 3 years 
 
Target Sample Size   Total Sample Size="4"
Sample Size from India="4" 
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   N/A 
Date of First Enrollment (India)   10/12/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic myeloid leukemia (CML) is one of the common types of blood cancer. In the current era, the standard initial therapy for most of the patients with CML is a medicine called imatinib. It was previously thought that imatinib needs to be given life-long for patients with CML. However, several studies over the past decade have shown that, in a selected group of patients with CML, it is possible to discontinue imatinib and see if their disease continues to remain under control even without medicines. In scientific terms, this is known as treatment-free remission (TFR). In this study, we will be evaluating the outcomes of TFR in patients with CML.

 


 
Close