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 |
Name (Synonyms) | Correlation | |
---|---|---|
D015470 | Leukemia, Myeloid, Acute NIH | 1.00 |
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 |
Name (Synonyms) | Correlation | |
---|---|---|
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
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).
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 treatmentDescription: 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 yearDescription: 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.
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