|drug830||Camidanlumab Tesirine Wiki||0.41|
|drug1169||Data registry Wiki||0.41|
|D007945||Leukemia, Lymphoid NIH||0.47|
|D006689||Hodgkin Disease NIH||0.41|
There are 6 clinical trials
The purpose of this study is to test the effects of a drug called Voraxaze when it's routinely given in combination with methotrexate and rituximab, the standard treatment for CNSL.
Description: All serum samples will be tested via MTX immunoassay (measures MTX levels in addition to byproducts) as well as HPLC or mass spectroscopy which will reveal plasma concentrations of MTX and DAMPA separately.Measure: number of patients that have significant reduction of serum methotrexate levels Time: 1 year
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.
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
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
The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).Measure: Objective Response Rate (ORR) Time: Up to 3 years
Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.Measure: Duration of Response (DOR) Time: Up to 3 years
Description: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.Measure: Complete Response (CR) Rate Time: Up to 3 years
Description: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.Measure: Relapse-Free Survival (RFS) Time: Up to 3 years
Description: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.Measure: Progression-Free Survival (PFS) Time: Up to 3 years
Description: OS defined as the time from first dose of study drug until death due to any cause.Measure: Overall Survival (OS) Time: Up to 3 years
Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: An SAE is defined as any adverse event (AE) that: results in death. is life threatening. requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE). results in persistent or significant disability/incapacity. is a congenital anomaly/birth defect. important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab TesirineMeasure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
Description: Determine the rate of severe neurotoxicities, >/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cellsMeasure: Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities Time: 4 weeks
Description: proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.Measure: Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation Time: 28 days from the start of treatment
The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20). The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma. Translated with www.DeepL.com/Translator (free version)
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 . 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.
Description: Hematological pathology DescriptionMeasure: Prognostic factors for healing of COVID-19 infection Time: Day 0
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
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