CML ADVOCATES NETWORK

Clinical Trials

ASC4INDIA (CABL001A2005) = Asciminib in Previously Treated Patients With Ph+ CML-CP With or Without T315I Mutation [India]

Study title

Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation

Scientific title

A Prospective, Multicenter, Single-arm, Open-label, Phase IV, Post-authorization Interventional Study to Assess the Safety and Efficacy of Asciminib in Indian Patients With Ph+ CML-CP (Without T315I Mutation), Previously Treated With Two or More Tyrosine Kinase Inhibitors and Ph+ CML-CP With T315I Mutation

Type of study

Post-authorization study; trial after therapy failure or intolerance

Phase

4

Current status

Active, not recruiting

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Other trial ID

ClinicalTrials.gov NCT06427811

What is the purpose of the study

The purpose of this study is to confirm the safety and efficacy of asciminib in Indian patients with Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia in chronic phsae (CML-CP) without T315I mutation, previously treated with 2 or more tyrosine kinase inhibitors (TKIs), and in patients with Ph+ CML-CP with T315I mutation.

 

What will happen during the study

The study will include 3 periods: a screening period (up to 21 days), a treatment period of up to 6 months with asciminib (with dosing according to mutation status), and a safety follow-up period for 30 days after the last dose of the study treatment. Completion of the safety follow-up period after the last dose of the study treatment will be considered as the End of Study.

Participants without T315I mutation will receive 80 mg once daily at approximately the same time each day OR 40 mg twice daily per Investigator’s discretion at approximately 12-hour intervals.

Participants with T315I mutation will receive 200 mg twice daily at approximately 12-hour intervals.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older.
  • have been diagnosed with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP).
  • have laboratory values as specified in the study protocol.
  • are willing to provide written informed consent prior to study enrollment.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • are in known second chronic phase of CML after previous progression to CML accelerated phase (AP) or CML blast phase (BC)
  • have previously received treatment with a hematopoietic stem-cell transplantation.
  • have heart conditions as specified in the study protocol.
  • have severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

November 2026

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Study Director: Novartis Pharmaceuticals

Principal investigator

Study centers / principal investigators

India

Novartis Investigative Site
Ahmedabad, Gujrat, 380009

Novartis Investigative Site
Ahmedabad, Gujrat, 382428

Novartis Investigative Site
Bengaluru, Karnataka, 560034

Novartis Investigative SiteTrivandrum, Kerala, 695011

Novartis Investigative Site
Pune, Maharashtra, 422001

Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 431005

Novartis Investigative Site
Hyderabad, Telangana, 500082

Novartis Investigative Site
Kolkata, West Bengal, 700014

Novartis Investigative Site
Cuttack, 753007

Novartis Investigative Site
Guwahati, 781003