Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04877522

Asciminib Roll-over Study

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Myelogenous Leukemia Blast Crisis Bone Marrow Diseases Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

7 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

Loading trial locations.

About this study

This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
  • Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.

Key Exclusion Criteria:

  • Participant has been discontinued from parent study treatment.
  • Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
  • Participant's ongoing treatment is currently approved and reimbursed at country level.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
  • Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
  • Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:
  • Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
  • QTcF>480msec or inability to determine QTc interval
  • any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment

Other protocol-defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Asciminib single agent

Drug

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Other names: ABL001

Imatinib

Drug

Taken orally, once daily, in the morning with low-fat meal

Other names: STI571

Nilotinib

Drug

Taken orally, twice daily, on an empty stomach

Other names: AMN107

Bosutinib

Drug

Taken orally, once daily, with food

dasatinib

Drug

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Other names: Sprycel

Asciminib single agent pediatric formulation

Drug

Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.

Other names: ABL001

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 8 years

    All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.

Secondary outcomes

  1. Percentage of participants with clinical benefit as assessed by Investigator

    Time frame: 8 years

    Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open Label, Multi-center Asciminib Roll-over 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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
May 7, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.