|drug542||Best Available Therapy (BAT) Wiki||1.00|
There is one clinical trial.
The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are refractory to Janus Kinase (JAK)-Inhibitor treatment.
Description: Overall survival is defined as the time interval from randomization date to date of death from any cause.Measure: Overall survival Time: Baseline (Day 1) until End of Study (EOS) (approximately 3 years)
Description: The proportion of participants achieving a ≥50% reduction in Total Symptom Score (TSS) measured at Week 24 compared to baselineMeasure: Symptom response rate Time: Baseline (Day 1), and at Week 24
Description: Progression-free survival is defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment [IWG-MRT] criteria) or death from any cause, whichever occurs first.Measure: Progression-free survival Time: Baseline (Day 1) until End of Study (EOS) (approximately 3 years)
Description: The proportion of participants who achieve a reduction in spleen volume of ≥ 35% from baseline at Week 24.Measure: Spleen response rate Time: Baseline (Day 1), and at Week 24
Description: The proportion of participants achieving CR or PR, CI, spleen response, symptom response, and anemia response per modified 2013 IWG-MRT criteriaMeasure: Complete remission, PR, CI, spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria Time: Baseline (Day 1) until End of Treatment (approximately 3 years)
Description: Reduction in the degree of bone marrow fibrosis will be assessed.Measure: Reduction in the degree of bone marrow fibrosis Time: Baseline (Day 1) until End of Treatment (approximately 3 years)
Description: Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatmentMeasure: Number of Participants with Adverse Events Time: Screening (Day -28 to -1) until End of Study (approximately 3 years)
Description: Maximum Observed Plasma Concentration (Cmax).Measure: Assessment of Cmax Time: Day 1 of all cycles (each cycle is 28 days)
Description: Patient-reported outcomes including health-related quality of life, pain, and overall change in participant's health will be assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are transformed to a 0 to 100 scale. Higher scores indicated worse outcome.Measure: European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores Time: Baseline to End of Study (approximately 3 years)
Description: EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).Measure: EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores Time: Baseline to End of Study (approximately 3 years)
Description: Area under the drug concentration-plasma time curve from time zero to last measurable concentrationMeasure: Assessment of AUC Time: Day 1 of all cycles (each cycle is 28 days)
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports