Skip to main content
OpenTrials
Completed

NCT Number: NCT05421091

Special Drug Use-results Surveillance of Scemblix Tablets

Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Anjo, Aichi-ken, Japan

Loading trial locations.

About this study

The objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients treated with asciminib in Japan.

Exclusion criteria

NA

Treatment and study plan

Asciminib

Other

Prospective observational study. There is no treatment allocation. Patients prescribed with asciminib are eligible to enroll into this study.

Primary outcomes

  1. Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications

    Time frame: Up to 48 Weeks

    For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), type, frequency AE, seriousness, severity of adverse event (AE)/treatment-related AE will be collected

  2. AEs leading to interruption/discontinuation of the safety specifications

    Time frame: Up to 48 Weeks

    For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), AEs leading to interruption/discontinuation will be collected

  3. Number of patients with changes in relevant laboratory parameters for the safety specifications

    Time frame: Up to 48 Weeks

    For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), number of patients with changes in relevant laboratory parameters will be collected

  4. Frequency of AEs/Treatment-related AEs by patient characteristic factor

    Time frame: Up to 48 Weeks

    Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected

Secondary outcomes

  1. Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set

    Time frame: Up to 48 Weeks

    Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set will be collected

  2. AEs leading to interruption/discontinuation in the safety analysis set

    Time frame: Up to 48 Weeks

    AEs leading to interruption/discontinuation in the safety analysis set will be collected

  3. Frequency of AEs/treatment-related AEs summarized by patient characteristic factor

    Time frame: Up to 48 Weeks

    Frequency of AEs/treatment-related AEs summarized by patient characteristic factor will be collected

  4. Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics

    Time frame: Up to 48 Weeks

    Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected

  5. AEs leading to interruption/discontinuation in patients with special characteristics

    Time frame: Up to 48 Weeks

    AEs leading to interruption/discontinuation in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women) will be collected

  6. Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line

    Time frame: Up to 48 Weeks

    Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line will be collected

  7. Factors affecting occurrence of AEs by treatment line

    Time frame: Up to 48 Weeks

    Factors affecting occurrence of AEs by treatment line will be collected

  8. AEs leading to interruption/discontinuation by treatment line

    Time frame: Up to 48 Weeks

    AEs leading to interruption/discontinuation by treatment line will be collected

  9. Major molecular response (MMR) rates

    Time frame: Week 12, Week 24, Week 48

    Major molecular response is defined as BCR-ABL1 International Scale value ≤ 0.1%.

    BCR-ABL1: translocation-produced fusion gene

  10. MMR rates by Week 48 by patient characteristics factor

    Time frame: Up to 48 Weeks

    Major molecular response (MMR) is defined as BCR-ABL1 International Scale value ≤ 0.1%.

    BCR-ABL1: translocation-produced fusion gene

  11. MR4.0 and MR4.5 rates

    Time frame: Week 12, Week 24 and Week 48

    MR4.0 and MR4.5 rates are defined as :

    • MR4.0: BCR-ABL1 International Scale value ≤ 0.01%
    • MR4.5: BCR-ABL1 International Scale value ≤ 0.0032%

    BCR-ABL1: translocation-produced fusion gene

  12. Complete cytogenetic response (CCyR) rates

    Time frame: Week 12, Week 24 and Week 48

    This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.

  13. Complete hematological response (CHR) rates

    Time frame: Week 12, Week 24 and Week 48

    This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

    • White blood cell count < 10,000/µL
    • Platelet count < 450,000/µL
    • No blast cell and promyelocyte in peripheral blood
    • Myelocyte + metamyelocyte in peripheral blood = 0%
    • Basophil < 5%
    • No spleen and liver swelling, and no extramedullary lesion

  14. Rate of patients with BCR-ABL1 gene mutations

    Time frame: Up to 48 Weeks

    This study will collect the rate of patients with BCR-ABL1 gene mutations

  15. MMR rates by Week 48 in patients with special characteristics

    Time frame: Week 48

    This study will collect major molecular response (MMR) rates by Week 48 in patients with special characteristics (patients with concurrent renal impairment/hepatic impairment/cardiac impairment, elderly, children, pregnant/parturient women)

  16. MMR rates by treatment line

    Time frame: Week 12, Week 24 and Week 48

    This study will collect major molecular response (MMR) rates by treatment line

  17. MR4.0 and MR4.5 rates by treatment line

    Time frame: Week 12, Week 24 and Week 48

    MR4.0 and MR4.5 rates are defined as :

    • MR4.0: BCR-ABL1 International Scale value ≤ 0.01%
    • MR4.5: BCR-ABL1 International Scale value ≤ 0.0032%

    BCR-ABL1: translocation-produced fusion gene

  18. CCyR rates by treatment line

    Time frame: Week 12, Week 24 and Week 48

    This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.

  19. CHR rates by treatment line

    Time frame: Week 12, Week 24 and Week 48

    This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria.

    • White blood cell count < 10,000/µL
    • Platelet count < 450,000/µL
    • No blast cell and promyelocyte in peripheral blood
    • Myelocyte + metamyelocyte in peripheral blood = 0%
    • Basophil < 5%
    • No spleen and liver swelling, and no extramedullary lesion

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Special Drug Use-results Surveillance of Scemblix Tablets (Resistant or Intolerant Chronic Myeloid Leukemia , CABL001A1401)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 16, 2022
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.