Asciminib Roll-over Study

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

Conditions

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

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Study Overview

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Study Details

Study 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

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

Asciminib Roll-over Study

Condition
Chronic Myelogenous Leukemia
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Michigan Med University of Michigan, Ann Arbor, Michigan, United States, 48109 5271

New York

Memorial Sloan Kettering, New York, New York, United States, 10017

Portland

Oregon Health Sciences University, Portland, Oregon, United States, 97239

Houston

Uni Of TX MD Anderson Cancer Cntr, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2030-08-30