CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D009190: Myelodysplastic Syndromes NIH

(Synonyms: Myelody, Myelodys, Myelodysp, Myelodyspl, Myelodyspla, Myelodysplasti, Myelodysplastic, Myelodysplastic S, Myelodysplastic Sy, Myelodysplastic Syn, Myelodysplastic Syndr, Myelodysplastic Syndrom, Myelodysplastic Syndrome, Myelodysplastic Syndromes)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)


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

Correlated MeSH Terms (7)


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

Correlated HPO Terms (4)


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

Clinical Trials


1 A Phase 1/2 Study of ALX148 in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS)

This Phase 1/2 clinical study will evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

NCT04417517 Higher Risk Myelodysplastic Syndromes Drug: ALX148 Drug: Azacitidine
MeSH:Preleukemia Myelodysplastic Syndromes Syndrome
HPO:Myelodysplasia

Primary Outcomes

Description: Number of participants with a DLT

Measure: Phase 1: Dose Limiting Toxicities (DLT)

Time: Up to 28 days

Description: Number of participants achieving a response per International Working Group (IWG) criteria

Measure: Phase 2: Objective response rate (ORR)

Time: Approximately 6 months

2 Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In

This 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.

NCT04439006 Aplastic Anemia Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Monoclonal B-Cell Lymphocytosis Monoclonal Gammopathy of Undetermined Significance Myelodysplastic Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Drug: Ibrutinib
MeSH:Laboratory Infection Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis Neoplasms
HPO:Aplastic anemia Erythroid hypoplasia Hypoplastic anemia Lymphocytosis Myelodysplasia Neoplasm

Primary Outcomes

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 registration

Measure: Death

Time: During hospitalization for COVID-19 infection or within 30 days of registration

Secondary Outcomes

Description: 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 days

Description: 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 days

Measure: Time in intensive care unit (ICU)

Time: Up to 14 days

Measure: Time to ICU admission

Time: Up to 14 days

Measure: Number of days requiring supplemental oxygen

Time: Up to 14 days

Measure: Total days of mechanical ventilation

Time: Up to 14 days

Measure: Time to mechanical ventilation

Time: Up to 14 days

Measure: Shock and need for pressure support

Time: Up to 14 days

Measure: Incidence of any infection (viral, fungal, bacterial)

Time: Up to 14 days

Measure: Time to clinical resolution

Time: Up to 14 days

Description: 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 months

Description: 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 days

Description: 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 months

Description: 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


HPO Nodes