Name (Synonyms) | Correlation | |
---|---|---|
drug311 | Azacitidine Wiki | 0.71 |
drug381 | Barrier box Wiki | 0.71 |
drug82 | ALX148 Wiki | 0.71 |
drug1370 | Ibrutinib Wiki | 0.50 |
drug394 | Best Practice Wiki | 0.41 |
Name (Synonyms) | Correlation | |
---|---|---|
D011289 | Preleukemia NIH | 0.71 |
D000741 | Anemia, Aplastic NIH | 0.71 |
D010265 | Paraproteinemias NIH | 0.71 |
D008998 | Monoclonal Gammopathy of Undetermined Significance NIH | 0.71 |
D008218 | Lymphocytosis NIH | 0.71 |
D009369 | Neoplasms, NIH | 0.15 |
D013577 | Syndrome NIH | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002863 | Myelodysplasia HPO | 1.00 |
HP:0100827 | Lymphocytosis HPO | 0.71 |
HP:0012133 | Erythroid hypoplasia HPO | 0.71 |
HP:0002664 | Neoplasm HPO | 0.15 |
There are 2 clinical trials
This Phase 1/2 clinical study will evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
Description: Number of participants with a DLT
Measure: Phase 1: Dose Limiting Toxicities (DLT) Time: Up to 28 daysDescription: Number of participants achieving a response per International Working Group (IWG) criteria
Measure: Phase 2: Objective response rate (ORR) Time: Approximately 6 monthsThis phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.
Description: Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.
Measure: Proportion of patients with diminished respiratory failure and death Time: During hospitalization for COVID-19 infection or within 30 days of registrationDescription: Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time from study initiation to 48 hours fever-free Time: Up to 14 daysDescription: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Duration of hospitalization Time: Up to 14 daysDescription: Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.
Measure: Incidence of grade 3 or higher adverse events Time: Up to 12 monthsDescription: The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.
Measure: At the end of therapy (day 14) Time: Up to 14 daysDescription: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.
Measure: Time to viral clearance Time: Up to 12 monthsDescription: Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.
Measure: Survival Time: Up to12 months