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Recruiting NCT04877522

Asciminib Roll-over Study

Phase IV Interventional Chronic Myelogenous Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Asciminib single agent, Imatinib, Nilotinib, Bosutinib.
Who it may be relevant to
Registry conditions: Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive. Basic parameters: 7 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Austria, Brazil, Bulgaria +24
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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.

Interventions

  • Drug Asciminib single agent
    Taken orally, twice daily (BID) or once daily (QD), in fasting state
  • Drug Imatinib
    Taken orally, once daily, in the morning with low-fat meal
  • Drug Nilotinib
    Taken orally, twice daily, on an empty stomach
  • Drug Bosutinib
    Taken orally, once daily, with food
  • Drug Dasatinib
    Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
  • 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.

Primary outcome measures

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: 8 years]
Secondary outcome measures (1)
  • Percentage of participants with clinical benefit as assessed by Investigator [Time frame: 8 years]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 12 centers
  • Novartis Investigative Site — Chongqing
  • Novartis Investigative Site — Guangzhou
  • Novartis Investigative Site — Zhengzhou
  • Novartis Investigative Site — Wuhan
  • Novartis Investigative Site — Changchun
  • Novartis Investigative Site — Xian
  • Novartis Investigative Site — Chengdu
  • Novartis Investigative Site — Beijing
  • … and 4 more centers
Spain · 12 centers
  • Novartis Investigative Site — Santiago Compostela
  • Novartis Investigative Site — Badalona
  • Novartis Investigative Site — L'Hospitalet de Llobregat
  • Novartis Investigative Site — Bilbao
  • Novartis Investigative Site — Santa Cruz
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Madrid
  • … and 4 more centers
United States · 6 centers
  • Michigan Med University of Michigan — Ann Arbor
  • Memorial Sloan Kettering — New York
  • Oregon Health Sciences University — Portland
  • Texas Oncology — Dallas
  • Uni Of TX MD Anderson Cancer Cntr — Houston
  • Medical College of Wisconsin — Milwaukee
France · 6 centers
  • Novartis Investigative Site — Bordeaux
  • Novartis Investigative Site — Lyon
  • Novartis Investigative Site — Marseille
  • Novartis Investigative Site — Nantes
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Vandœuvre-lès-Nancy
Germany · 4 centers
  • Novartis Investigative Site — Frankfurt am Main
  • Novartis Investigative Site — Jena
  • Novartis Investigative Site — Berlin
  • Novartis Investigative Site — Kiel
Poland · 4 centers
  • Novartis Investigative Site — Katowice
  • Novartis Investigative Site — Krakow
  • Novartis Investigative Site — Warsaw
  • Novartis Investigative Site — Wroclaw
Russia · 4 centers
  • Novartis Investigative Site — Moscow
  • Novartis Investigative Site — Moscow
  • Novartis Investigative Site — Saint Petersburg
  • Novartis Investigative Site — Saint Petersburg
South Korea · 4 centers
  • Novartis Investigative Site — Uijeongbu-si
  • Novartis Investigative Site — Busan
  • Novartis Investigative Site — Jeollanam
  • Novartis Investigative Site — Seoul
Brazil · 3 centers
  • Novartis Investigative Site — Rio de Janeiro
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
Italy · 3 centers
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Roma
  • Novartis Investigative Site — Naples
Malaysia · 3 centers
  • Novartis Investigative Site — George Town
  • Novartis Investigative Site — Johor Bahru
  • Novartis Investigative Site — Kuala Selangor
Argentina · 2 centers
  • Novartis Investigative Site — CABA
  • Novartis Investigative Site — Capital Federal
Austria · 2 centers
  • Novartis Investigative Site — Graz
  • Novartis Investigative Site — Vienna
Czechia · 2 centers
  • Novartis Investigative Site — Ostrava
  • Novartis Investigative Site — Brno
Portugal · 2 centers
  • Novartis Investigative Site — Lisbon
  • Novartis Investigative Site — Porto
United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Vietnam · 2 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 1 center
  • Novartis Investigative Site — Varna
Canada · 1 center
  • Novartis Investigative Site — Montreal
Denmark · 1 center
  • Novartis Investigative Site — Copenhagen
Japan · 1 center
  • Novartis Investigative Site — Kobe
Lebanon · 1 center
  • Novartis Investigative Site — Beirut
Mexico · 1 center
  • Novartis Investigative Site — Monterrey
Oman · 1 center
  • Novartis Investigative Site — Khoudh
Romania · 1 center
  • Novartis Investigative Site — Timișoara
Saudi Arabia · 1 center
  • Novartis Investigative Site — Riyadh
Singapore · 1 center
  • Novartis Investigative Site — Singapore
Taiwan · 1 center
  • Novartis Investigative Site — Taoyuan
Turkey (Türkiye) · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04877522 · CABL001A2001B · 2021-000602-17 · 2023-507557-16-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗