Status:
RECRUITING
Asciminib Roll-over Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Eligibility:
All Genders
7-100 years
Phase:
PHASE4
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
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 Novarti...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT04877522
Start Date
August 30 2022
End Date
August 30 2030
Last Update
November 3 2025
Active Locations (83)
Enter a location and click search to find clinical trials sorted by distance.
1
Michigan Med University of Michigan
Ann Arbor, Michigan, United States, 48109 5271
2
Memorial Sloan Kettering
New York, New York, United States, 10017
3
Oregon Health Sciences University
Portland, Oregon, United States, 97239
4
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States, 77030