A Real-world Study of Asciminib Effectiveness in Philadelphia Positive Acute Lymphoblastic Leukemia Patients

NCT07644351 | Completed

• 1 other identifier: CABL001A2007
• Study Type: observational
• Target: 37
• Locations: 12 countries
• Sites: 18

Brief Summary

The aim of this study was to collect existing information from the medical charts of patients enrolled in the ongoing asciminib Managed Access Program (MAP) to better understand the effectiveness and safety of asciminib when used to treat adult patients with Ph+ ALL who are refractory, resistant or intolerant to available treatments.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Asciminib; Ph+ ALL; Real world study

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving Hematological Complete Remission (CR) or Hematological Complete Remission With Incomplete Count Recovery (CRi) in the First 3 Months of Treatment

  Hematological CR was defined as no circulating lymphoblasts, absolute neutrophil count (ANC) ≥1,000/μL, platelets ≥100K/μL. Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.

  3 months

Secondary Outcomes (17)

• Proportion of Patients With Minimal Residual Disease (MRD) Evaluated in Peripheral Blood at Best Response

  From Day 1 to 120, and at Baseline, Day 28, 60, 90, 180, 270, 360

• Proportion of Patients Who Showed MRD Positivity and MRD Negativity

  Baseline, Day 28, 60, 90, 180, 270, 360

• Duration of Response (DoR)

  Up to 5 years and 4 months

• Proportion of Patients in Hematological CR or CRi Within 13 Months From Start of Treatment

  By Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)

• Proportion of Patients in Complete Remission

  Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)

Study Arms (1)

Asciminib Cohort

Ph+ ALL patients who received at least one dose of asciminib through the asciminib MAP.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Ph+ ALL who were enrolled in the asciminib MAP and received at least one dose of asciminib.

You may qualify if:

• Adult patients enrolled in the asciminib MAP.
• Diagnosis of Ph+ ALL.
• Patients received at least one dose of asciminib through the asciminib MAP.
• Appropriate approval obtained for the use of patient data including:
• Signed informed consent form (ICF), or
• ICF waiver granted by an Institutional review board/Independent Ethics Committee (IRB/IEC).

You may not qualify if:

• Age \< 18 years at the time of initiating asciminib treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

Sydney, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Montreal, H1T 2M4, Canada

Location

Novartis Investigative Site

Hong Kong, China

Location

Novartis Investigative Site

Le Chesnay, 78150, France

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Ascoli Piceno, 63100, Italy

Location

Novartis Investigative Site

Bari, 70124, Italy

Location

Novartis Investigative Site

Catania, 95123, Italy

Location

Novartis Investigative Site

Cuneo, 12100, Italy

Location

Novartis Investigative Site

Pescara, 65124, Italy

Location

Novartis Investigative Site

Torino, 10126, Italy

Location

Novartis Investigative Site

Rotterdam, 3015, Netherlands

Location

Novartis Investigative Site

Islamabad, 44000, Pakistan

Location

Novartis Investigative Site

Rawalpindi, 46000, Pakistan

Location

Novartis Investigative Site

Bialystok, 15-276, Poland

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: December 16, 2024
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6); CN (1); FR (1); US (1); IL (1); AU (1); NL (1); PA (2); PL (1); ES (1); GB (1); CA (1)