Recruiting

Asciminib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT04877522

Conditions

Chronic Myelogenous Leukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

Interventions

Asciminib single agent

Imatinib

Nilotinib

Bosutinib

Dasatinib

Study Details

Brief summary:

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

Conditions

Chronic Myelogenous Leukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study ID

NCT04877522

Start date

Aug 30, 2022

Status verified date

Jul, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Aug 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

347 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Asciminib single agent group

Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib

other: Bosutinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib

experimental: Bosutinib-Asciminib switch group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

experimental: Asciminib in combination with imatinib group

Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

experimental: Asciminib in combination with nilotinib group

Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

other: Imatinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib

other: Nilotinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib

experimental: Asciminib in combination with dasatinib group

Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib

other: Dasatinib single agent group

Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.

experimental: Dasatinib-Asciminib switch group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study

experimental: Asciminib single agent formulation for Pediatric

Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib

Interventions

Asciminib single agent

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

Imatinib

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

Nilotinib

Taken orally, twice daily, on an empty stomach

Bosutinib

Taken orally, once daily, with food

Dasatinib

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

Asciminib single agent pediatric formulation

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.

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Michigan Med University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109 5271

Contacts

Kelly Whitley

kwhitley@med.umich.edu

Principal Investigator:

Moshe Talpaz

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10017

Contacts

Shakira Pascual

646-497-9068pascuals@mskcc.org

Principal Investigator:

Michael Mauro

Texas Oncology

Recruiting

Dallas, Texas, United States, 75251

Contacts

Jessica Maner

+1 214 370 1000Jessica.Maner@usoncology.com

Principal Investigator:

Moshe Yair Levy

Uni Of TX MD Anderson Cancer Cntr

Recruiting

Houston, Texas, United States, 77030

Contacts

Susan Aline Wahl

+1 713 792 2921sawahl2@mdanderson.org

Principal Investigator:

Fadi Haddad

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Esta Konkol

414-805-6803ekonkol@mcw.edu

Principal Investigator:

Ehab Atallah

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Chronic Myelogenous Leukemia
  • CML
  • ALL
  • CML-AP
  • CML-BP
  • CML-CP
  • myeloproliferative neoplasm
  • chronic phase
  • accelerated phase
  • blast phase
  • ABL001
  • asciminib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-06.