Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07354074
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Myelogenous Leukemia
  • Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Asciminib single agent — DRUG
    Asciminib (labelled as ABL001) administered as 40 mg tablet (adult formulation) or as 1 mg film-coated granules mini-tablets (pediatric formulation)

Study Details

The aim of this study is to support development of asciminib in the pediatric population (1 to \< 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.

Key Dates

First listed
Jan 21, 2026
Start date
Apr 28, 2026
Status verified
Jul 2026
Primary completion
Feb 23, 2033
Completion
Feb 23, 2033

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm study
    This study will enroll pediatric patients (≥ 1 and \< 18 years of age) with newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

Primary Outcome Measure

MMR at Week 48 [ Time Frame: 48 weeks ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Jesmin Habeeb Mohamed
[email protected]
Richard DRACHTMAN (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center New York PresbyterianNew YorkNew York10032
Karishma Sookraj
[email protected]
212-305-6953
Nobuko Hijiya (PRINCIPAL_INVESTIGATOR)

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By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJColumbia University Medical Center New York Presbyterian· New York, NY

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