Asciminib Roll-over Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Chronic Myelogenous Leukemia
• Intervention / Treatment: Drug: Asciminib single agent; Drug: Bosutinib; Drug: Asciminib; Drug: Imatinib; Drug: Nilotinib; Drug: Dasatinib

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 the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.

• Study Type: Interventional
• Enrollment (Estimated): 347
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1221ADC
      • Recruiting
      • Novartis Investigative Site
• Austria
  • Wien, Austria, 1140
    • Recruiting
    • Novartis Investigative Site
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20211-030
      • Recruiting
      • Novartis Investigative Site
  • SP
    • Sao Paulo, SP, Brazil, 05403 000
      • Recruiting
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 08270-070
      • Recruiting
      • Novartis Investigative Site
• Bulgaria
  • Varna, Bulgaria, 9000
    • Recruiting
    • Novartis Investigative Site
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Novartis Investigative Site
• Czechia
  • Brno-Bohunice, Czechia, 639 00
    • Recruiting
    • Novartis Investigative Site
  • Poruba
    • Ostrava, Poruba, Czechia, 708 52
      • Recruiting
      • Novartis Investigative Site
• Denmark
  • Copenhagen, Denmark, DK-2100
    • Recruiting
    • Novartis Investigative Site
• France
  • Bordeaux, France, 33076
    • Recruiting
    • Novartis Investigative Site
  • Marseille, France, 13273
    • Recruiting
    • Novartis Investigative Site
  • Paris 10, France, 75475
    • Recruiting
    • Novartis Investigative Site
  • Vandoeuvre les Nancy, France, 54511
    • Recruiting
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Recruiting
    • Novartis Investigative Site
  • Jena, Germany, 07740
    • Recruiting
    • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80132
    • Recruiting
    • Novartis Investigative Site
  • MI
    • Milano, MI, Italy, 20162
      • Recruiting
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00161
      • Recruiting
      • Novartis Investigative Site
• Japan
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Active, not recruiting
      • Novartis Investigative Site
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Completed
    • Novartis Investigative Site
  • Jeollanam, Korea, Republic of, 519763
    • Active, not recruiting
    • Novartis Investigative Site
  • Gyeonggi Do
    • Uijeongbu si, Gyeonggi Do, Korea, Republic of, 11759
      • Active, not recruiting
      • Novartis Investigative Site
• Lebanon
  • Beirut, Lebanon, 1107 2020
    • Active, not recruiting
    • Novartis Investigative Site
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Recruiting
      • Novartis Investigative Site
• Poland
  • Krakow, Poland, 30-688
    • Active, not recruiting
    • Novartis Investigative Site
  • Warszawa, Poland, 02 776
    • Recruiting
    • Novartis Investigative Site
  • Wroclaw, Poland, 50 367
    • Completed
    • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1099 023
    • Recruiting
    • Novartis Investigative Site
  • Porto, Portugal, 4200-072
    • Recruiting
    • Novartis Investigative Site
• Romania
  • Timisoara, Romania, 300079
    • Recruiting
    • Novartis Investigative Site
• Russian Federation
  • Moscow, Russian Federation, 125167
    • Recruiting
    • Novartis Investigative Site
  • Moscow, Russian Federation, 125284
    • Recruiting
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197341
    • Recruiting
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 191024
    • Recruiting
    • Novartis Investigative Site
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • Active, not recruiting
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 169608
    • Active, not recruiting
    • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Novartis Investigative Site
  • Madrid, Spain, 28006
    • Recruiting
    • Novartis Investigative Site
  • Valencia, Spain, 46026
    • Recruiting
    • Novartis Investigative Site
  • Andalucia
    • Sevilla, Andalucia, Spain, 41009
      • Recruiting
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Recruiting
      • Novartis Investigative Site
    • Hospitalet de LLobregat, Catalunya, Spain, 08907
      • Recruiting
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Recruiting
      • Novartis Investigative Site
• Taiwan
  • Taoyuan, Taiwan, 33305
    • Active, not recruiting
    • Novartis Investigative Site
• Turkey
  • Samsun, Turkey, 55139
    • Recruiting
    • Novartis Investigative Site
• United Kingdom
  • Oxford, United Kingdom, OX3 7LJ
    • Recruiting
    • Novartis Investigative Site
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109 5271
      • Recruiting
      • Michigan Med University of Michigan .
      • Principal Investigator: Moshe Talpaz
  • New York
    • New York, New York, United States, 10017
      • Recruiting
      • Memorial Sloan Kettering
      • Contact: Dalisa Espinosa; Phone Number: 646-497-9068; Email: espinosD@mskcc.org
      • Principal Investigator: Michael Mauro
  • Oregon
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health Sciences University .
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Uni of TX MD Anderson Cancer Cntr
      • Contact: Phone Number: 713-792-2921
      • Principal Investigator: Koji Sasaki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 only for participants on bosutinib treatment that switch to asciminib treatment at enrollment:

   • Asymptomatic pancreatitis
   • abnormal ECG
   • 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bosutinib single agent group; Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, 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 ABL001A2301 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 ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib	Drug: Asciminib; Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state; Other Names: ABL001; 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 ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib	Drug: Asciminib; Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state; Other Names: ABL001; Drug: Imatinib; Taken orally, once daily, in the morning with low-fat meal; Other Names: STI571
Other: Imatinib single agent group; Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 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 ABL001E2201 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 ABL001X2101 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
Experimental: Asciminib single agent group; Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib	Drug: Asciminib single agent; Taken orally, twice daily (BID) or once daily (QD), in fasting state; Other Names: ABL001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participabts with adverse events (AEs) and serious adverse events (SAEs)	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with clinical benefit as assessed by Investigator	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.	5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ALL; CML; Chronic Myelogenous Leukemia; ABL001; CML-CP; asciminib; myeloproliferative neoplasm; chronic phase; CML-AP; accelerated phase; CML-BP; blast phase
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chronic Disease; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Micronutrients; Protein Kinase Inhibitors; Vitamins; Vitamin B Complex; Tyrosine Kinase Inhibitors; Imatinib Mesylate; Dasatinib; Niacinamide; Nilotinib; Bosutinib; Asciminib
• Other Study ID Numbers: CABL001A2001B; 2021-000602-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No