Covid 19 Research using Clinical Trials (Home Page)
Report for D015470: Leukemia, Myeloid, Acute NIH
(Synonyms: Leukemia, Myeloid, Acut, Leukemia, Myeloid, Acute)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1359 | IO-202 Dose Escalation Wiki | 0.71 |
| drug1361 | IO-202 Dose Expansion B Wiki | 0.71 |
| drug1360 | IO-202 Dose Expansion A Wiki | 0.71 |
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007951 | Leukemia, Myeloid, NIH | 0.71 |
| D007938 | Leukemia, NIH | 0.71 |
| D015477 | Leukemia, Myelomonocytic, Chronic NIH | 0.71 |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH | 0.50 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004808 | Acute myeloid leukemia HPO | 1.00 |
| HP:0012324 | Myeloid leukemia HPO | 0.71 |
| HP:0012325 | Chronic myelomonocytic leukemia HPO | 0.71 |
| HP:0001909 | Leukemia HPO | 0.43 |
There are 2 clinical trials
Clinical Trials
1 A Phase I Study of IO-202 as Monotherapy and in Combination With Azacitidine in Relapsed/ Refractory AML With Monocytic Differentiation and in Relapsed/Refractory CMML
To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with relapsed or refractory monocytic AML and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D) and dose schedule as monotherapy and in combination with azacitidine (AZA).
NCT04372433 AML M5 AML M4 AML, Nos Acute Myelogenous Leukemia in Relapse Myelomonocytic Leukemia, Chronic Drug: IO-202 Dose Escalation Drug: IO-202 Dose Expansion A Drug: IO-202 Dose Expansion B MeSH:Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Chronic myelomonocytic leukemia Leukemia Myeloid leukemia
Primary Outcomes
Description: Incidence of adverse events
Measure: Safety of IO-202 as measured by incidence of adverse events. Time: From first dose of IO-202 to 30 days following last study treatment
Description: Severity of adverse events
Measure: Safety of IO-202 as measured by severity of adverse events. Time: From first dose of IO-202 to 30 days following last study treatment
Description: Incidence dose interruptions and dose reductions
Measure: Tolerability of IO-202 as measured by incidence and duration of dose interruptions and dose reductions of study treatment Time: From first dose of IO-202 to 30 days following last study treatment
Secondary Outcomes
Description: Maximum concentration (Cmax) of IO-202
Measure: To characterize the pharmacokinetics (PK) of IO-202 as defined by maximum plasma concentration (Cmax) Time: Through study completion, an average of 1 year
Description: measure area under the curve (AUC) of IO-202
Measure: To characterize the PK of IO-202 as defined by area under the curve (AUC) Time: Through study completion, an average of 1 year
Description: Measure anti-drug antibodies in plasma.
Measure: To evaluate the incidence of anti-drug antibodies against IO-202 Time: Through study completion, an average of 1 year
Description: Measure response rates in patients with anti-drug antibodies.
Measure: To measure rates of response to IO-202 in patients with anti-drug antibodies Time: Through study completion, an average of 1 year
Description: Measure response rates by bone marrow examination of blast percentage.
Measure: Measure response rates in patients treated with IO-202 or IO-202 in combination with AZA Time: Through study completion, an average of 1 year
Other Outcomes
Description: Measure changes in numbers of lymphocytes with study drug treatment
Measure: To assess changes in lymphocytes with IO-202 or IO-202 in combination with AZA Time: Through study completion, a average of 1 year
Description: Measure changes in blood immune proteins with study drug treatment
Measure: To measure blood immune proteins with IO-202 or IO-202 in combination with AZA Time: Through study completion, a average of 1 year
Description: Statistical correlation levels of target expression on leukemic blasts with response rate
Measure: To correlate target expression with response rates Time: Through study completion, a average of 1 year
Description: Statistical correlation of target expression on leukemic blasts with adverse event rates
Measure: To correlate target expression with rates of adverse events Time: Through study completion, a average of 1 year
Description: Measure immunophenotype of leukemic blasts from bone marrow aspirates after study treatment
Measure: To evaluate immunophenotype of leukemic blasts after study treatment. Time: Through study completion, a average of 1 year
2 National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
Primary Outcomes
Description: Incidence of adverse events
Measure: Safety of IO-202 as measured by incidence of adverse events. Time: From first dose of IO-202 to 30 days following last study treatmentDescription: Severity of adverse events
Measure: Safety of IO-202 as measured by severity of adverse events. Time: From first dose of IO-202 to 30 days following last study treatmentDescription: Incidence dose interruptions and dose reductions
Measure: Tolerability of IO-202 as measured by incidence and duration of dose interruptions and dose reductions of study treatment Time: From first dose of IO-202 to 30 days following last study treatmentSecondary Outcomes
Description: Maximum concentration (Cmax) of IO-202
Measure: To characterize the pharmacokinetics (PK) of IO-202 as defined by maximum plasma concentration (Cmax) Time: Through study completion, an average of 1 yearDescription: measure area under the curve (AUC) of IO-202
Measure: To characterize the PK of IO-202 as defined by area under the curve (AUC) Time: Through study completion, an average of 1 yearDescription: Measure anti-drug antibodies in plasma.
Measure: To evaluate the incidence of anti-drug antibodies against IO-202 Time: Through study completion, an average of 1 yearDescription: Measure response rates in patients with anti-drug antibodies.
Measure: To measure rates of response to IO-202 in patients with anti-drug antibodies Time: Through study completion, an average of 1 yearDescription: Measure response rates by bone marrow examination of blast percentage.
Measure: Measure response rates in patients treated with IO-202 or IO-202 in combination with AZA Time: Through study completion, an average of 1 yearOther Outcomes
Description: Measure changes in numbers of lymphocytes with study drug treatment
Measure: To assess changes in lymphocytes with IO-202 or IO-202 in combination with AZA Time: Through study completion, a average of 1 yearDescription: Measure changes in blood immune proteins with study drug treatment
Measure: To measure blood immune proteins with IO-202 or IO-202 in combination with AZA Time: Through study completion, a average of 1 yearDescription: Statistical correlation levels of target expression on leukemic blasts with response rate
Measure: To correlate target expression with response rates Time: Through study completion, a average of 1 yearDescription: Statistical correlation of target expression on leukemic blasts with adverse event rates
Measure: To correlate target expression with rates of adverse events Time: Through study completion, a average of 1 yearDescription: Measure immunophenotype of leukemic blasts from bone marrow aspirates after study treatment
Measure: To evaluate immunophenotype of leukemic blasts after study treatment. Time: Through study completion, a average of 1 yearThe COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.
NCT04452604 Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia SARS-CoV-2 MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia
Primary Outcomes
Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Measure: Clinical prognostic factors for infection with COVID-19 Time: Day 0
Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
Measure: Biological prognostic factors for infection with COVID-19 Time: Day 0
Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis
HPO Nodes
HP:0004808: Acute myeloid leukemia
Genes 48
CHIC2 LPP TCIRG1 SRSF2 KIT MLLT10 KRAS DNMT3A PICALM DNAJC21 TERT TET2 FLT3 RPS14 ELANE ASXL1 JAK2 KIT CEBPA SRP54 MPL RUNX1 GATA2 DKC1 SRP54 NPM1 CBFB RUNX1 SH3GL1 JAK2 SRP54 SF3B1 SBDS DDX41 ERBB3 DNAJC21 BRCA2 SBDS ETV6 PIGA NUP214 THPO EFL1 GFI1 GFI1 TET2 TET2 DNAJC21
Primary Outcomes
Description: Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Measure: Clinical prognostic factors for infection with COVID-19 Time: Day 0Description: neutrophils and lymphocytes count at the time of SARS-COV2 infection
Measure: Biological prognostic factors for infection with COVID-19 Time: Day 0Description: Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis