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D054198: Precursor Cell Lymphoblastic Leukemia-Lymphoma

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 (2)


Name (Synonyms) Correlation
drug4050 Spectrila® Wiki 0.50
drug2250 Ixazomib Wiki 0.35

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D007938 Leukemia, NIH 0.47
D007945 Leukemia, Lymphoid NIH 0.45
D015470 Leukemia, Myeloid, Acute NIH 0.29
Name (Synonyms) Correlation
D008223 Lymphoma, NIH 0.16
D003922 Diabetes Mellitus, Type 1 NIH 0.14
D003920 Diabetes Mellitus, NIH 0.08

Correlated HPO Terms (6)


Name (Synonyms) Correlation
HP:0005526 Lymphoid leukemia HPO 0.45
HP:0001909 Leukemia HPO 0.35
HP:0004808 Acute myeloid leukemia HPO 0.29
Name (Synonyms) Correlation
HP:0002665 Lymphoma HPO 0.16
HP:0100651 Type I diabetes mellitus HPO 0.14
HP:0000819 Diabetes mellitus HPO 0.08

Clinical Trials

Navigate: Correlations   HPO

There are 4 clinical trials


1 A Clinical Phase II Trial to Describe Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Spectrila® With the Pharmaceutical Active Ingredient Recombinant L Asparaginase in Adult Subjects With Newly Diagnosed Acute B-Cell Lymphoblastic Leukaemia

This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for first-line treatment of ALL patients of all age groups and showed similar efficacy and safety in comparison to Asparaginase medac no blinding or control groups are necessary. As underlying treatment protocol the BRALL 2014 treatment protocol will be used.

NCT03156790
Conditions
  1. Acute B-Cell Lymphoblastic Leukaemia
Interventions
  1. Drug: Spectrila®
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO:Leukemia Lymphoid leukemia

Primary Outcomes

Description: Assessment of induction phase response, defined as subjects with asparaginase (ASNase) activity trough levels in serum ≥ 100 U/L in induction phase

Measure: Asparaginase (ASNase) activity trough levels

Time: Day 21 until Day 31
2 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
Conditions
  1. Precursor Cell Lymphoblastic Leukemia-lymphoma
Interventions
  1. 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
3 National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

The 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
Conditions
  1. Acute Myeloblastic Leukemia
  2. Acute Lymphoblastic Leukemia
  3. 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
4 Hb A1C Pre and Post Confinement in Latin American Children With Type 1 Diabetes: Dulce Study Group

A multicenter retrospective observational study among children with type 1 diabetes will be performed. The Objective of this study will be to determine a) the association between the increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the association between the frequency of patient care during social confinement and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.

NCT04640064
Conditions
  1. Type1diabetes
  2. Childhood ALL
MeSH:Precursor Cell Lymphoblastic Leukemi Precursor Cell Lymphoblastic Leukemia-Lymphoma Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: The increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic

Measure: Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes

Time: six months

HPO Nodes


HPO

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Reports

Data processed on December 13, 2020.

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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