Asciminib Roll-over Study

Purpose

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

Eligibility

Eligible Ages
Between 7 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: Asciminib single agent
    Taken orally, twice daily (BID) or once daily (QD), in fasting state
    Other names:
    • ABL001
Other
Bosutinib single agent group 		Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
  • Drug: Bosutinib
    Taken orally, once daily, with food
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
  • Drug: Asciminib single agent
    Taken orally, twice daily (BID) or once daily (QD), in fasting state
    Other names:
    • ABL001
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
  • Drug: Imatinib
    Taken orally, once daily, in the morning with low-fat meal
    Other names:
    • STI571
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
  • Drug: Nilotinib
    Taken orally, twice daily, on an empty stomach
    Other names:
    • AMN107
Other
Imatinib single agent group 		Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
  • Drug: Imatinib
    Taken orally, once daily, in the morning with low-fat meal
    Other names:
    • STI571
Other
Nilotinib single agent group 		Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
  • Drug: Nilotinib
    Taken orally, twice daily, on an empty stomach
    Other names:
    • AMN107
Experimental
Asciminib in combination with dasatinib group 		Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
  • Drug: Dasatinib
    Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
    Other names:
    • Sprycel
Other
Dasatinib single agent group 		Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
  • Drug: Dasatinib
    Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
    Other names:
    • Sprycel
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
  • Drug: Asciminib single agent
    Taken orally, twice daily (BID) or once daily (QD), in fasting state
    Other names:
    • ABL001
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
  • Drug: 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.
    Other names:
    • ABL001

Recruiting Locations

Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
Contact:
Kelly Whitley
kwhitley@med.umich.edu

Memorial Sloan Kettering
New York, New York 10017
Contact:
Shakira Pascual
646-497-9068
pascuals@mskcc.org

Texas Oncology
Dallas, Texas 75251
Contact:
Jessica Maner
+1 214 370 1000
Jessica.Maner@usoncology.com

Uni Of TX MD Anderson Cancer Cntr
Houston, Texas 77030
Contact:
Susan Aline Wahl
+1 713 792 2921
sawahl2@mdanderson.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Esta Konkol
414-805-6803
ekonkol@mcw.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

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

Detailed Description

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.