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D009190: Myelodysplastic Syndromes

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (9)


Name (Synonyms) Correlation
drug1034 Diagnostic Laboratory Biomarker Analysis Wiki 0.50
drug1165 Electronic Health Record Review Wiki 0.50
drug384 BNT162b1 Wiki 0.41
Name (Synonyms) Correlation
drug1601 Ibrutinib Wiki 0.41
drug463 Biospecimen Collection Wiki 0.35
drug385 BNT162b2 Wiki 0.35
drug425 Best Practice Wiki 0.32
drug2732 Questionnaire Administration Wiki 0.20
drug2490 Placebo Wiki 0.03

Correlated MeSH Terms (10)


Name (Synonyms) Correlation
D000741 Anemia, Aplastic NIH 0.71
D010265 Paraproteinemias NIH 0.71
D008998 Monoclonal Gammopathy of Undetermined Significance NIH 0.71
Name (Synonyms) Correlation
D008218 Lymphocytosis NIH 0.71
D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.50
D009196 Myeloproliferative Disorders NIH 0.41
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.41
D007938 Leukemia, NIH 0.35
D008223 Lymphoma, NIH 0.29
D009369 Neoplasms, NIH 0.26

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0100827 Lymphocytosis HPO 0.71
HP:0012133 Erythroid hypoplasia HPO 0.71
HP:0002863 Myelodysplasia HPO 0.71
Name (Synonyms) Correlation
HP:0002664 Neoplasm HPO 0.13

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 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
Conditions
  1. Aplastic Anemia
  2. Hematopoietic and Lymphoid Cell Neoplasm
  3. Malignant Solid Neoplasm
  4. Monoclona
  5. Monoclonal B-Cell Lymphocytosis
  6. Monoclonal Gammopathy of Undetermined Significance
  7. Myelodysplastic Syndrome
  8. Symptomatic COVID-19 Infection Laboratory-Confirmed
Interventions
  1. Other: Best Practice
  2. Drug: Ibrutinib
MeSH:Laboratory Infection Neoplasms Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis
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
2 Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer

This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.

NCT04666025
Conditions
  1. Accelerated Phase CML, BCR-ABL1 Positive
  2. Acute Lymphoblastic Leukemia
  3. Acute Myeloid Leukemia
  4. Chronic Lymphocytic Leukemia
  5. Chronic Phase CML, BCR-ABL1 Positive
  6. COVID-19 Infection
  7. Hematopoietic and Lymphoid Cell Neoplasm
  8. Hodgkin Lymphoma
  9. Lymphoblastic Lymphoma
  10. Myelodysplastic Syndrome
  11. Myelofibrosis
  12. Myeloproliferative Neoplasm
  13. Non-Hodgkin
  14. Non-Hodgkin Lymphoma
Interventions
  1. Procedure: Biospecimen Collection
  2. Other: Diagnostic Laboratory Biomarker Analysis
  3. Other: Electronic Health Record Review
  4. Other: Questionnaire Administration
MeSH:Lymphoma Leukemia Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Myelodysplastic Syndromes Myeloproliferative Disorders
HPO:Chronic lymphatic leukemia Leukemia Lymphoma Myelodysplasia Myeloproliferative disorder Neoplasm

Primary Outcomes

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.

Measure: Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels

Time: Up to 180 days post-hematopoietic stem cell transplant (HCT)

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

Measure: SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels

Time: Up to 180 days post-HCT

Description: Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.

Measure: SARS-CoV-2 neutralizing antibodies

Time: Up to 180 days post-HCT

Secondary Outcomes

Description: Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA.

Measure: SARS-CoV-2 IgA concentration

Time: Up to 180 days post-HCT

Other Outcomes

Description: The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S or SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.

Measure: SARS-CoV-2 -specific T cell memory profile and associated function

Time: Up to 180 days post-HCT

HPO Nodes


Reports

Data processed on January 01, 2021.

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.

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706 reports on MeSH terms

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306 reports on HPO terms

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Alphabetical index of all Terms

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