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D007938: 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 (5)


Name (Synonyms) Correlation
drug1598 IO-202 Dose Escalation Wiki 0.45
drug3180 Spectrila® Wiki 0.45
drug1006 Data registry Wiki 0.45
Name (Synonyms) Correlation
drug1599 IO-202 Dose Expansion Wiki 0.45
drug1762 Ixazomib Wiki 0.32

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D007945 Leukemia, Lymphoid NIH 0.77
D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma NIH 0.77
D015470 Leukemia, Myeloid, Acute NIH 0.63
Name (Synonyms) Correlation
D007951 Leukemia, Myeloid, NIH 0.45
D010007 Osteochondritis NIH 0.45
D015479 Leukemia, Myelomonocytic, Acute NIH 0.45
D015477 Leukemia, Myelomonocytic, Chronic NIH 0.45
D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.45
D008223 Lymphoma, NIH 0.37

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0005526 Lymphoid leukemia HPO 0.77
HP:0001909 Leukemia HPO 0.65
HP:0004808 Acute myeloid leukemia HPO 0.63
Name (Synonyms) Correlation
HP:0012324 Myeloid leukemia HPO 0.45
HP:0012325 Chronic myelomonocytic leukemia HPO 0.45
HP:0005550 Chronic lymphatic leukemia HPO 0.45
HP:0002665 Lymphoma HPO 0.37

Clinical Trials

Navigate: Correlations   HPO

There are 5 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 A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered IO-202 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Chronic Myelomonocytic Leukemia (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.

NCT04372433
Conditions
  1. AML M5
  2. AML M4
  3. AML, Nos
  4. Acute Myelogenous Leukemia in Relapse
  5. Myelomonocytic Leukemia, Chronic
Interventions
  1. Drug: IO-202 Dose Escalation
  2. Drug: IO-202 Dose Expansion
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Acute myelomonocytic 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

Other Outcomes

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
4 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.

NCT04391946
Conditions
  1. Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
Interventions
  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
5 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

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook