Covid 19 Research using Clinical Trials (Home Page)
Report for D007938: Leukemia NIH
(Synonyms: Leu, Leuk, Leuke, Leukem, Leukemi, Leukemia, Leukemia,, Leukemia,)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1359 | IO-202 Dose Escalation Wiki | 0.50 |
| drug1361 | IO-202 Dose Expansion B Wiki | 0.50 |
| drug1360 | IO-202 Dose Expansion A Wiki | 0.50 |
| drug848 | Data registry Wiki | 0.50 |
| drug1505 | Ixazomib Wiki | 0.35 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007945 | Leukemia, Lymphoid NIH | 0.71 |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH | 0.71 |
| D015470 | Leukemia, Myeloid, Acute NIH | 0.71 |
| D007951 | Leukemia, Myeloid, NIH | 0.50 |
| D010007 | Osteochondritis NIH | 0.50 |
| D015477 | Leukemia, Myelomonocytic, Chronic NIH | 0.50 |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell NIH | 0.50 |
| D008223 | Lymphoma, NIH | 0.45 |
Correlated HPO Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004808 | Acute myeloid leukemia HPO | 0.71 |
| HP:0005526 | Lymphoid leukemia HPO | 0.71 |
| HP:0001909 | Leukemia HPO | 0.60 |
| HP:0012324 | Myeloid leukemia HPO | 0.50 |
| HP:0012325 | Chronic myelomonocytic leukemia HPO | 0.50 |
| HP:0005550 | Chronic lymphatic leukemia HPO | 0.50 |
| HP:0002665 | Lymphoma HPO | 0.45 |
There are 4 clinical trials
Clinical Trials
1 Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.
NCT03888534 Precursor Cell Lymphoblastic Leukemia-lymphoma Drug: Ixazomib MeSH:Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia Lymphoma
Primary Outcomes
Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy Time: Up to Day 29
Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Time: Up to 30 months
Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters Time: Up to 30 months
Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Secondary Outcomes
Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measure: Overall Response Rate (ORR) Time: Up to 30 months
2 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
Primary Outcomes
Description: DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measure: Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy Time: Up to Day 29Measure: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Time: Up to 30 months
Measure: Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters Time: Up to 30 months
Measure: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Measure: Cmax: Maximum Observed Plasma Concentration for Ixazomib Time: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Secondary Outcomes
Description: ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measure: Overall Response Rate (ORR) Time: Up to 30 monthsTo 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
3 National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
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) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012. Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.
NCT04391946 Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease Behavioral: Data registry MeSH:Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Osteochondritis
HPO:Chronic lymphatic leukemia Leukemia Lymphoid leukemia Lymphoma
Primary Outcomes
Description: Hematological pathology Description
Measure: Prognostic factors for healing of COVID-19 infection Time: Day 0
Secondary Outcomes
Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosis
Description: Allow national epidemiological monitoring and regularly inform the hematology community.
Measure: national epidemiological monitoring Time: through study completion, an average of 2 years
4 National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
Primary Outcomes
Description: Hematological pathology Description
Measure: Prognostic factors for healing of COVID-19 infection Time: Day 0Secondary Outcomes
Description: Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measure: Medical care of Coronavirus infection Time: within 12 months after diagnosisDescription: Allow national epidemiological monitoring and regularly inform the hematology community.
Measure: national epidemiological monitoring Time: through study completion, an average of 2 yearsThe 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:0001909: Leukemia
Genes 190
TREM2 CBL TERT CEP57 PICALM ATRX TERT FANCD2 RPS15A RPS24 FANCE PIK3R1 GATA1 STS ELANE WIPF1 JAK2 GATA1 SRP54 LIG4 POT1 GATA2 PTPN11 MLH1 XRCC4 SRP54 TET2 TET2 LIG4 EP300 NPM1 RARA SH3GL1 PDGFRA RPL5 ERBB3 RUNX1 KRAS PIGL GATA2 NUTM1 ETV6 PIGL THPO DYNC2LI1 RPS26 GFI1 CBL WAS RPL18 SH2B3 ABL1 LPP ATM SRSF2 TP53 NRAS DNMT3A DNAJC21 RPS27 RPS7 MPL RPL26 DNMT3A RPS29 CALR ASXL1 CEBPA ELANE TSR2 RUNX1 DKC1 APC ADAR NUP214 GLI1 HAX1 IFIH1 SCN9A MYD88 EVC RUNX1 SAMHD1 NSUN2 CREBBP TRIP13 SRP54 SBDS SH2B3 RUNX1 DNAJC21 TP53 RPS10 MPL BCR GATA2 CALR BUB1B FLT3 CALR NRAS SETBP1 MSH2 SH2B3 SAMD9L FANCC BCR TCIRG1 BLM ADA2 PIK3CA SRSF2 FANCG GATA2 MYD88 KIF11 TET2 FLT3 JAK2 KIT RPS17 NBN RB1 NUMA1 BRD4 TREX1 THPO SMPD1 RPL35 BUB3 RNASEH2C PDGFRB SF3B1 RPS28 MSH6 DDX41 PMS2 RPL35A BAX BUB1 TERC TET2 DNAJC21 RPL11 CHIC2 BLM FANCA KIT RPL31 MLLT10 RPL15 RNASEH2A KRAS TAL2 EVC2 RPS14 SCN10A RPS19 MPL ASXL1 SAMD9L RNASEH2B CBL JAK2 NF1 ABL1 CBFB ARHGAP26 BUB1B NBN SCN11A TET2 MPL JAK2 F13A1 RPL27 BCR BRCA2 SBDS F13B GNB1 TAL1 PIGA NUP214 TYROBP EFL1 GFI1 TET2 JAK2 KRAS Protein Mutations 56
C282Y C481S D816V D835Y E255K E255V F317C F317L F317S F317V F31I F359C F359V G250E G71R H369P H63D L248R L248V L265P L858R N291S N682S P13K P140K P1446A P4503A Q12H Q252H R132C R132G R132H R132L R132S R132V R140L R140Q R140W R172G R172K R172M R172S R172W S1612C S9333A T315A T315I T351I T790M V158M V299L V57I V600E V617F V66M Y253H
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