An observational study in Chronic Myeloid Leukemia, sponsored by Novartis Pharmaceuticals. Completed at 278 sites in Japan. Open to participants aged Up to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Novartis Pharmaceuticals · Observational
Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 550 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients treated with asciminib
Exclusion Criteria:
NA
Patients prescribed with Asciminib
Other: Asciminib
Prospective observational study. There is no treatment allocation. Patients prescribed with asciminib are eligible to enroll into this study.
Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications
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
Time frame: Up to 48 Weeks
AEs leading to interruption/discontinuation of the safety specifications
For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), AEs leading to interruption/discontinuation will be collected
Time frame: Up to 48 Weeks
Number of patients with changes in relevant laboratory parameters for the safety specifications
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
Time frame: Up to 48 Weeks
Frequency of AEs/Treatment-related AEs by patient characteristic factor
Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected
Time frame: Up to 48 Weeks
Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set
Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set will be collected
Time frame: Up to 48 Weeks
AEs leading to interruption/discontinuation in the safety analysis set
AEs leading to interruption/discontinuation in the safety analysis set will be collected
Time frame: Up to 48 Weeks
Frequency of AEs/treatment-related AEs summarized by patient characteristic factor
Frequency of AEs/treatment-related AEs summarized by patient characteristic factor will be collected
Time frame: Up to 48 Weeks
Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics
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
Time frame: Up to 48 Weeks
AEs leading to interruption/discontinuation in patients with special characteristics
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
Time frame: Up to 48 Weeks
Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line
Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line will be collected
Time frame: Up to 48 Weeks
Factors affecting occurrence of AEs by treatment line
Factors affecting occurrence of AEs by treatment line will be collected
Time frame: Up to 48 Weeks
AEs leading to interruption/discontinuation by treatment line
AEs leading to interruption/discontinuation by treatment line will be collected
Time frame: Up to 48 Weeks
Major molecular response (MMR) rates
Major molecular response is defined as BCR-ABL1 International Scale value ≤ 0.1%. BCR-ABL1: translocation-produced fusion gene
Time frame: Week 12, Week 24, Week 48
MMR rates by Week 48 by patient characteristics factor
Major molecular response (MMR) is defined as BCR-ABL1 International Scale value ≤ 0.1%. BCR-ABL1: translocation-produced fusion gene
Time frame: Up to 48 Weeks
MR4.0 and MR4.5 rates
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
Time frame: Week 12, Week 24 and Week 48
Complete cytogenetic response (CCyR) rates
This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.
Time frame: Week 12, Week 24 and Week 48
Complete hematological response (CHR) rates
This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria. 1. White blood cell count \< 10,000/µL 2. Platelet count \< 450,000/µL 3. No blast cell and promyelocyte in peripheral blood 4. Myelocyte + metamyelocyte in peripheral blood = 0% 5. Basophil \< 5% 6. No spleen and liver swelling, and no extramedullary lesion
Time frame: Week 12, Week 24 and Week 48
Rate of patients with BCR-ABL1 gene mutations
This study will collect the rate of patients with BCR-ABL1 gene mutations
Time frame: Up to 48 Weeks
MMR rates by Week 48 in patients with special characteristics
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)
Time frame: Week 48
MMR rates by treatment line
This study will collect major molecular response (MMR) rates by treatment line
Time frame: Week 12, Week 24 and Week 48
MR4.0 and MR4.5 rates by treatment line
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
Time frame: Week 12, Week 24 and Week 48
CCyR rates by treatment line
This study will collect complete cytogenetic response (CCyR), which is defined as a state of Ph+ metaphase cell disappearance, i.e. Ph+ cell = 0%.
Time frame: Week 12, Week 24 and Week 48
CHR rates by treatment line
This study will collect complete hematological response (CHR), which is defined as meeting the following 6 criteria. 1. White blood cell count \< 10,000/µL 2. Platelet count \< 450,000/µL 3. No blast cell and promyelocyte in peripheral blood 4. Myelocyte + metamyelocyte in peripheral blood = 0% 5. Basophil \< 5% 6. No spleen and liver swelling, and no extramedullary lesion
Time frame: Week 12, Week 24 and Week 48
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals