| CTRI Number |
CTRI/2025/11/097880 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment |
|
Scientific Title of Study
|
An open label multi-center asciminib rollover study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2023-507557-16-00 |
EudraCT |
| CABL001A2001B; Version No. 03; Dated 17 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India.
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India.
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Country Monitoring Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai, MAHARASHTRA - 400051, India.
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250243544 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG , Novartis Campus 4056 - Basel , Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
7 floor, Inspire BKC, G Block, BKC Main Road Bandra Kurla
Complex, Bandra East Mumbai 400051 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Novartis Healthcare Private Limited |
Inspire BKC, Part of 601 & 701,
BKC Main Road, Bandra Kurla Complex,
Bandra (East), Mumbai (India) – 400051, Maharashtra. |
|
|
Countries of Recruitment
|
Argentina
Austria
Brazil
Bulgaria
Canada
China
Czech Republic
Denmark
France
Germany
Greece
Hungary
India
Italy
Japan
Jordan
Lebanon
Malaysia
Mexico
Oman
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
South Africa
Spain
Switzerland
Taiwan
Turkey
United Arab Emirates
United Kingdom
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parathan Karunakaran |
Adyar cancer institute |
Cancer Institute WIA, No. 38, Sardar Patel Road, Dr. S.K. Campus, Adyar,
Chennai, Tamil Nadu - 600036
Chennai
TAMIL NADU |
8220773477
k.parathan@cancerinstitutewia.org |
| Dr Manoranjan mahapatra |
All india institute of medical sciences |
Department of Hematology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Delhi - 110029
New Delhi
DELHI |
9810337214
mrmahapatra@hotmail.com |
| Dr Uttam Kumar Nath |
All india institute of medical sciences |
Department of Medical Oncology Haematology, AIIMS, Rishikesh, Veerbhadra Road, Rishikesh, Uttarakhand - 249203
Dehradun
UTTARANCHAL |
9433982756
nath.uttam@gmail.com |
| Dr Anil singh |
Homi Bhabha Cancer Hospital |
Ghanti Mill Road, Lahartara, Old Loco Colony, Shivpurwa, Varanasi, Uttar
Pradesh - 221010
Varanasi
UTTAR PRADESH |
7905004119
anilsingh8520@gmail.com |
| Dr Sandip Shah |
Vedanta institute of medical science |
Hemato Oncology Clinic Ahmedabad Pvt. Ltd., Ground Floor and First
Floor, Vedanta Institute of
Medical Science, Nr.Samved Hospital, Navrangpura, Ahmedabad,
Gujarat - 380009
Ahmadabad
GUJARAT |
7926402220
drsandip.hocvedanta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of CIMS |
Approved |
| Ethics Committee relating to Clinical Trial All India Institute of Medical Sciences Rishikesh |
Approved |
| IEC MPMMCC and HBCH Varanasi |
Submittted/Under Review |
| Institute Ethics Committee All India Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee Cancer Institute WIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Asciminib |
Asciminib 80 mg Tablet once daily orally for 242 weeks. |
| Comparator Agent |
NA |
NA |
| Intervention |
Nilotinib |
Nilotinib 300 mg Hard Gelatin Capsule twice daily orally for 242 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant with Ph+ CML or Ph+ ALL, currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib) or study treatment received in the comparator arm while enrolled within a Novartis-sponsored study, who has fulfilled the requirements for the primary objective and has completed treatment phase and, in the opinion of the Investigator, would benefit from continued treatment. |
|
| ExclusionCriteria |
| Details |
1.Participant has been discontinued from parent study treatment due to any reason.
2.Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have:
•not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities,
•not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities.
3.Participant’s ongoing treatment is currently approved and reimbursed at country level. In exceptional cases where the treatment is reimbursed at country but not individual level, please contact the Novartis Study Team.
4.Pregnant or nursing (lactating) women.
5.Women of child-bearing potential unless they are using highly effective methods of contraception.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The frequency and severity of AEs/SAEs |
At every 12 weeks from baseline till end of treatment visit (Week 242) and Safety Follow-up visit (30 days after last dose) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of participants with clinical benefit as assessed by the investigator
|
At every 12 weeks from baseline till Week 240. |
|
|
Target Sample Size
|
Total Sample Size="357"
Sample Size from India="23"
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 3 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/08/2022 |
| 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)
|
Open to Recruitment |
| 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
|
The
purpose of this study is to assess long-term safety and provide continued
treatment with asciminib single agent or in combination with imatinib,
nilotinib, dasatinib, or imatinib,
nilotinib, dasatinib or bosutinib as single agent for participants with Philadelphia
Chromosome positive chronic myelogenous leukemia (Ph+ CML) or Ph+ acute lymphoblastic
leukemia (Ph+ ALL, a type of blood cancer) who have completed a Novartis
sponsored asciminib clinical study (parent study) and, in the opinion of
the investigator, would benefit from continuing treatment, but are unable to
access treatment outside of a clinical study. |