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    HP:0005526: Lymphoid leukemia

    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 (3)

    Name (Synonyms) Correlation
    drug3180 Spectrila® Wiki 0.58
    drug1006 Data registry Wiki 0.58
    drug1762 Ixazomib Wiki 0.41

    Correlated MeSH Terms (6)

    Name (Synonyms) Correlation
    D007945 Leukemia, Lymphoid NIH 1.00
    D007938 Leukemia, NIH 0.77
    D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.67
    Name (Synonyms) Correlation
    D010007 Osteochondritis NIH 0.58
    D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.58
    D008223 Lymphoma, NIH 0.47

    Correlated HPO Terms (3)

    Name (Synonyms) Correlation
    HP:0005550 Chronic lymphatic leukemia HPO 0.58
    HP:0001909 Leukemia HPO 0.50
    HP:0002665 Lymphoma HPO 0.47

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 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.

    1. Acute B-Cell Lymphoblastic Leukaemia
    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.

    1. Precursor Cell Lymphoblastic Leukemia-lymphoma
    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 Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

    The 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.

    1. Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
    1. 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

    HPO Nodes


    Data processed on September 26, 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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