Name (Synonyms) | Correlation | |
---|---|---|
drug360 | Biosensors Wiki | 0.58 |
drug83 | ASP7517 Wiki | 0.58 |
drug72 | ALX148 Wiki | 0.58 |
drug260 | Azacitidine Wiki | 0.58 |
drug1163 | Ibrutinib Wiki | 0.41 |
drug332 | Best Practice Wiki | 0.33 |
Name (Synonyms) | Correlation | |
---|---|---|
D011289 | Preleukemia NIH | 0.82 |
D000741 | Anemia, Aplastic NIH | 0.58 |
D010265 | Paraproteinemias NIH | 0.58 |
D008998 | Monoclonal Gammopathy of Undetermined Significance NIH | 0.58 |
D008218 | Lymphocytosis NIH | 0.58 |
D007951 | Leukemia, Myeloid, NIH | 0.33 |
D015470 | Leukemia, Myeloid, Acute NIH | 0.29 |
D007938 | Leukemia, NIH | 0.24 |
D009369 | Neoplasms, NIH | 0.13 |
D013577 | Syndrome NIH | 0.13 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002863 | Myelodysplasia HPO | 1.00 |
HP:0100827 | Lymphocytosis HPO | 0.58 |
HP:0012133 | Erythroid hypoplasia HPO | 0.58 |
HP:0012324 | Myeloid leukemia HPO | 0.33 |
HP:0004808 | Acute myeloid leukemia HPO | 0.29 |
HP:0001909 | Leukemia HPO | 0.16 |
HP:0002664 | Neoplasm HPO | 0.13 |
There are 3 clinical trials
The purpose of this study is to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517. This study will also evaluate the clinical response of ASP7517 as well as other measures of anticancer activity of ASP7517.
Description: A DLT is defined as any of the following events that occur within 28 days starting with the first dose on cycle 1 day 1 (C1D1) and that is considered to be related to investigation product (IP). The severity of AEs will be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. DLT is defined as follows: non-hematologic AEs that are ≥ grade 3; confirmed Hy's law case; new onset of grade 4 thrombocytopenia (with minimum of 2 grade worsening from baseline) within 24 hours of dosing; prolonged myelosuppression, defined as absolute neutrophil count (ANC) < 500/μL for more than 28 days off therapy and in the absence of evidence of active leukemia or MDS in the marrow or blood, will be considered as a DLT.
Measure: Incidence of dose limiting toxicities (DLTs) Time: 28 daysDescription: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be graded using NCI-CTCAE guidelines, version 5.0.
Measure: Number of participants with adverse events (AEs) Time: Up to 2 yearsDescription: An AE is considered "serious" if the event: results in death; is life-threatening (An AE is considered "life-threatening" if its occurrence places the subject at immediate risk of death; it does not include an AE that, had it occurred in a more severe form, might have caused death.); results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); other medically important events.
Measure: Number of participants with serious adverse events (SAEs) Time: Up to 2 yearsDescription: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or AEs Time: Up to 2 yearsDescription: Routine 12-lead ECGs will be taken after the subject has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate.
Measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs Time: Up to 2 yearsDescription: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and/or AEs Time: Up to 2 yearsDescription: Number of participants with potentially clinically significant physical exam values.
Measure: Number of participants with physical exam abnormalities and/or AEs Time: Up to 2 yearsDescription: The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measure: Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status Time: Up to 2 yearsDescription: CRc rate is defined for AML subjects as the number of participants who achieve the best response of CRc (complete response [CR], complete remission with incomplete platelet recovery [CRp] or complete remission with incomplete hematological recovery [CRi]) divided by the number of participants in the analysis population.
Measure: Composite complete remission (CRc) rate for participants with R/R AML (phase 2) Time: Up to 2 yearsDescription: Complete response + bone marrow complete response + partial response (CR + BM CR + PR) rate for participants with R/R higher risk MDS (phase 2) [ Time Frame: Up to 2 years ] CR + BM CR + PR rate is defined for MDS participants as the number of participants who achieve the best response of CR + BM CR + PR divided by the number of subjects in the analysis population.
Measure: Complete response + bone marrow complete response + partial response (CR + BM CR + PR) rate for participants with R/R higher risk MDS (phase 2) Time: Up to 2 yearsDescription: Duration of remission for participants with AML includes duration of CRc, duration of CR/complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR, and duration of response (i.e., CRc + PR).
Measure: Duration of remission for participants with AML Time: Up to 2 yearsDescription: Duration of remission for MDS includes duration of CR and duration of response (i.e., CR + PR).
Measure: Duration of remission for participants with MDS Time: Up to 2 yearsDescription: EFS is defined as the time from the date of first dose until the date of documented relapse, treatment failure or death from any cause within 30 days after the last dose of study drug (whichever occurs first earliest of [relapse date, treatment failure date, death date] - first dose date + 1).
Measure: Number of participants with event-free survival (EFS) Time: Up to 2 yearsDescription: OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1).
Measure: Duration of overall survival (OS) Time: Up to 2 yearsDescription: CR rate is defined as the number of participants who achieve CR at any of the postbaseline visits divided by the number of participants in the analysis population.
Measure: CR rates for participants with R/R AML Time: Up to 2 yearsDescription: Best response rate is defined as the number of subjects who achieve CRc or PR at any of the postbaseline visits divided by the number of subjects in the analysis population.
Measure: Best response (CRc + PR) rates for participants with R/R AML Time: Up to 2 yearsDescription: CRh rate is defined as the number of participants who achieve CRh at any of the postbaseline visits divided by the number of participants in the analysis population.
Measure: CRh rates for participants with R/R AML Time: Up to 2 yearsDescription: CR rate is defined as the number of participants who achieve CR at any of the postbaseline visits divided by the number of participants in the analysis population.
Measure: CR rates for participants with R/R higher risk MDS Time: Up to 2 yearsDescription: HI requires 1 measurement of erythroid or platelets or neutrophils maintained at a specified level for at least 8 weeks without ongoing cytotoxic therapy
Measure: Hematologic improvement (HI) rates for participants with R/R higher risk MDS Time: Up to 2 yearsDescription: Objective response (CR + BM CR + PR + HI) rates (ORR) for participants with R/R higher risk MDS [Time Frame: Up to 2 years] ORR is defined as the number of participants who achieve CR or BM CR or PR or HI at any of the postbaseline visits divided by the number of participants in the analysis population.
Measure: Objective response (CR + BM CR + PR + HI) rates (ORR) for participants with R/R higher risk MDS Time: Up to 2 yearsThis 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