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HP:0012324: Myeloid leukemiaHPO

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


Correlated Drug Terms (8)


Name (Synonyms) Correlation
drug83 ASP7517 Wiki 0.58
drug2830 granulocyte colony-stimulating factor (G-CSF) Wiki 0.58
drug1154 IO-202 Dose Escalation Wiki 0.58
drug2823 fludarabine Wiki 0.58
drug1156 IO-202 Dose Expansion B Wiki 0.58
drug1155 IO-202 Dose Expansion A Wiki 0.58
drug2828 gilteritinib Wiki 0.58
drug2795 cytarabine Wiki 0.58

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D007951 Leukemia, Myeloid, NIH 1.00
D015470 Leukemia, Myeloid, Acute NIH 0.87
D007938 Leukemia, NIH 0.71
D015477 Leukemia, Myelomonocytic, Chronic NIH 0.58
D011289 Preleukemia NIH 0.41
D009190 Myelodysplastic Syndromes NIH 0.33
D013577 Syndrome NIH 0.06

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0004808 Acute myeloid leukemia HPO 0.87
HP:0012325 Chronic myelomonocytic leukemia HPO 0.58
HP:0001909 Leukemia HPO 0.48
HP:0002863 Myelodysplasia HPO 0.33

There are 3 clinical trials

Clinical Trials


1 A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

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.

NCT04079296 Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome Biological: ASP7517
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Syndrome
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia Myelodysplasia Myeloid leukemia

Primary Outcomes

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 days

Description: 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 years

Description: 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 years

Description: Number of participants with potentially clinically significant laboratory values.

Measure: Number of participants with laboratory value abnormalities and/or AEs

Time: Up to 2 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

2 A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation. One cycle is defined as 28 days of treatment. A participant completing 2 cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

NCT04240002 Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD) Drug: gilteritinib Drug: fludarabine Drug: cytarabine Drug: granulocyte colony-stimulating factor (G-CSF)
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Leukemia Myeloid leukemia

Primary Outcomes

Description: A DLT is defined as any of the events meeting the DLT criteria that occur during the observation period and that is considered to be possibly or probably related to gilteritinib. Nonhematologic Dose-limiting Toxicity will be defined as grade 3 or 4 nonhematologic toxicity attributable to gilteritinib that persists for > 48 hours without resolution to grade ≤ 2, will have gilteritinib dosing interrupted. Exceptions include the toxicities commonly seen with intensive AML reinduction regimens. Hematologic Dose-limiting Toxicity will be defined as failure to recover a peripheral absolute neutrophil count (ANC) > 500/μL and non-transfusion dependent platelet count > 20000/μL due to documented bone marrow aplasia/hypoplasia for greater than or equal to 50 days from the start of cycle 1 day 1. Failure to recover peripheral counts due to disease involvement of the bone marrow will not be considered dose-limiting toxicity.

Measure: Number of participants with dose limiting toxicity (DLT) (phase 1/dose escalation)

Time: Up to 28 days

Description: CR rate is defined as the number of participants who achieve the best response of CR divided by the number of participants in the analysis population. Complete remission is defined as having bone marrow regenerating normal hematopoietic cells and achieving a morphologic leukemia-free state and must have an absolute neutrophil count (ANC) ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they will be red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There should be no evidence of extramedullary leukemia.

Measure: Complete Remission (CR) rate after 2 cycles of therapy (phase 2)

Time: Up to 56 days

Description: CRc rate is defined as the number of participants who achieve the best response of CRc (CR, CRp,or CRi) divided by the number of participants in the analysis population. Complete remission with incomplete platelet recovery (CRp) is defined as achieving CR except for incomplete platelet recovery (< 100 x 10^9/L) at a post baseline visit. Complete remission with incomplete hematologic recovery (CRi) is defined as achieving CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery at a post baseline visit. Red blood cell (RBC) and platelet transfusion independence is not required.

Measure: Composite complete remission (CRc) rate after 2 cycles of therapy (phase 2)

Time: Up to 56 days

Secondary Outcomes

Description: 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.

Measure: Number of participants with Adverse Events (AEs)

Time: Up to 2 years plus 28 day follow up

Description: Number of participants with potentially clinically significant vital sign values.

Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs)

Time: Up to 2 years

Description: Number of participants with potentially clinically significant laboratory values.

Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)

Time: Up to 2 years

Description: Number of participants with potentially clinically significant ECG values.

Measure: Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)

Time: Up to 2 years

Description: Inhibition of FLT3 phosphorylation after drug treatment will be determined relative to pre-treatment phosphorylated FLT3 levels in participants to assess the relationship with gilteritinib dose. Phosphorylated FLT3 will be measured by plasma inhibitory activity (PIA) assay.

Measure: Percentage of inhibition of phosphorylated FLT3 in participants.

Time: Up to 49 days

Description: CL/F will be reported from the PK plasma samples collected.

Measure: Pharmacokinetics (PK) of gilteritinib: oral clearance (CL/F)

Time: Up to 45 days

Description: Vd/F will be reported from the PK plasma samples collected.

Measure: PK of gilteritinib: apparent volume of distribution (Vd/F)

Time: Up to 45 days

Description: Cmax will be reported from the PK plasma samples collected.

Measure: PK of gilteritinib: Maximum Concentration (Cmax)

Time: Up to 45 days

Description: tmax will be reported from the PK plasma samples collected.

Measure: PK of gilteritinib: Time of Maximum Concentration (tmax)

Time: Up to 45 days

Description: AUC will be reported from the PK plasma samples collected.

Measure: PK of gilteritinib: Area Under the Concentration (AUC)

Time: Up to 45 days

Description: EFS is defined as the time from the date of enrollment until the date of documented relapse (excluding relapse after PR), treatment failure or death, whichever occurs first. If a participant experiences relapse or death, the participant is defined as having EFS event related to either "relapse" or "death", and the event date is the date of relapse or death. If a participant fails to achieve any of the response of CR, CRp, CRi or PR during the treatment period, the participant is defined as having EFS event related to treatment failure, and the event date is the enrollment date. For a participant who is not known to have had a relapse or treatment failure or death event, EFS is censored at the date of last relapse-free disease assessment. Participant is not censored at hematopoietic stem cell transplant (HSCT).

Measure: Duration of Event Free Survival (EFS)

Time: Up to 2 years

Description: OS is defined as the time from the date of enrollment until the date of death from any cause. For a participant who is not known to have died by the end-of-study follow-up, OS is censored at the date of last contact.

Measure: Duration of Overall survival (OS)

Time: Up to 4 years and 2 months

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Measure: The number of participants with negative minimal residual disease (MRD) status

Time: Up to 2 years

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Measure: Number of participants with MRD negative status in relation to CR rate

Time: Up to 2 years

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Measure: Number of participants with MRD negative status in relation to CRc rate

Time: Up to 2 years

Description: MRD negative status will be defined as FLT3-internal tandem duplication (ITD) signal ratio ≤ 10^-4.

Measure: Number of participants with MRD negative status in relation to Overall survival (OS)

Time: Up to 2 years

Description: The acceptability and palatability of gilteritinib oral formulation as assessed by the participant using a single scale. The 5 point facial hedonic scale has high to low as: Liked it Very Much, Liked it a Little, Not sure, Disliked it a Little, Disliked it Very Much.

Measure: Clinical Outcome Assessment of Taste

Time: Up to 57 days

3 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


HPO Nodes