RECRUITING

Asciminib Roll-over Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-08-30
Study Completion:2030-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04877522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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.
  1. 1. Participant has been discontinued from parent study treatment.
  2. 2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
  3. 3. Participant's ongoing treatment is currently approved and reimbursed at country level.
  4. 4. Pregnant or nursing (lactating) women.
  5. 5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
  6. 6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
  7. 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:
  8. * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
  9. * QTcF\>480msec or inability to determine QTc interval
  10. * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Michigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271
United States
Memorial Sloan Kettering
New York, New York, 10017
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2030-08-30

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2030-08-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Myelogenous Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive