Home › Trials › NCT04877522

Long-term safety treatment for chronic myelogenous leukemia patients

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

Phase 4 Interventional Novartis · NCT04877522

This study is testing the long-term safety of a medication called asciminib for patients with chronic myelogenous leukemia who have already been part of another study.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment347 (estimated)
Ages7 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsasciminib, imatinib, nilotinib, dasatinib, bosutinib
Locations84 sites (Ann Arbor, Michigan and 83 other locations)
Trial IDNCT04877522 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center global roll-over study focuses on the long-term safety of asciminib for patients who have previously participated in a Novartis-sponsored study. Participants who are deemed by their investigator to benefit from continued treatment will receive asciminib or other approved therapies. The study aims to provide ongoing access to treatment for those unable to obtain it outside of the clinical setting. It includes patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia.

Who should consider this trial

Good fit: Ideal candidates are patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia who have previously participated in a Novartis-sponsored study and are currently receiving asciminib or other specified treatments.

Not a fit: Patients who have been discontinued from the parent study or have unresolved treatment-related toxicities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide ongoing access to effective treatment for patients with chronic myelogenous leukemia.

How similar studies have performed: Other studies involving asciminib have shown promising results, indicating that this approach is based on previously successful treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. 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.
2. 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:

1. Participant has been discontinued from parent study treatment.
2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
3. Participant's ongoing treatment is currently approved and reimbursed at country level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
7. 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.

Where this trial is running

Ann Arbor, Michigan and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCMLALLCML-APCML-BPCML-CPmyeloproliferative neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.