№ files_lp_3_process_9_32438
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Statistical analysis section of a clinical research study presenting weighted survival, mediation, interaction, and sensitivity analyses evaluating the effect of FLT3 inhibitor therapy versus conventional chemotherapy and the role of transplant in patients with FLT3-mutated acute myeloid leukemia.
Year:
Not specified
Disease:
Acute Myeloid Leukemia (AML)
Genetic Focus:
FLT3 mutations (TKD, ITD, ITD-TKD)
Treatment Groups:
FLT3 inhibitors (FLT3i) vs Conventional Chemotherapy (CT)
Endpoints:
Overall Survival (OS); Event-Free Survival (EFS); Time to Transplant
Study Period:
Before and after 2018 approval of FLT3 inhibitors
Statistical Methods:
Logistic regression; Propensity score weighting; Inverse probability weighting; Cox proportional hazard models; Mediation analysis; Sensitivity analysis
Confounders Considered:
Sex; Age; AML type; FLT3 mutation type; White-blood cell count; Platelet count; ELN risk classification; Ongoing comorbidities
Risk Classification System:
European LeukemiaNet (ELN)
Supplementary Material:
Table S1 (subgroup analyses with inverse probability weighting); Table S2 (baseline characteristic survival analyses)
Key Measures:
Hazard Ratios (HR); 95% Confidence Intervals (CI); p-values
Regulatory Milestone Referenced:
Clinical approval of FLT3 inhibitors in 2018
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Year:
2024
Region / City:
Australia
Theme:
Pharmaceutical benefits, Chronic myeloid leukaemia (CML) treatment
Document type:
Research analysis
Organization / Institution:
Drug Utilisation Sub-Committee (DUSC)
Author:
Drug Utilisation Sub-Committee (DUSC)
Target audience:
Healthcare professionals, policymakers, pharmaceutical industry
Period of validity:
From March 2022 onward
Approval date:
October 2024
Date of changes:
March 2022
Year:
2021
Region / city:
Australia
Topic:
Pharmaceutical Drug Submission
Document type:
Resubmission Request
Organization / institution:
PBAC
Author:
AbbVie Pty Ltd.
Target audience:
Healthcare professionals, PBAC
Validity period:
Not specified
Approval date:
2021
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Oncology / Hematology
Document Type:
Submission Report
Organ / Institution:
Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Celgene Pty Limited
Target Audience:
Healthcare professionals, regulatory authorities
Validity Period:
Ongoing
Approval Date:
8 April 2022
Amendment Date:
Not specified
Authors:
Myung Sup Kim; Hyeokgu Kang; Jung-Hwan Baek; Moon-Gyu Cho; EunJoo Chung; Seok-Jun Kim; Joon-Yong Chung; Kyung-Hee Chun
Corresponding author:
Kyung-Hee Chun
Affiliation:
Department of Biochemistry & Molecular Biology, Graduate School of Medical Science, Brain Korea 21 Project, Yonsei University College of Medicine, Seoul, Republic of Korea
Additional institutions:
Institute of Genetic Science, Yonsei University College of Medicine; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA; Chosun University, Gwangju, Republic of Korea
Region / Country:
Republic of Korea; United States of America
Type of document:
Supplementary figures and experimental descriptions for a biomedical research article
Field of study:
Cancer immunology; molecular and cellular biology
Key topics:
Notch signaling; HES1; macrophage differentiation; tumor-associated macrophages; CD8+ T cells; MMTV-PyMT mouse model; TC-1 tumor model
Experimental models:
Murine spontaneous and subcutaneous tumor models; MMTV-PyMT mice; LysM-Hes1 conditional knockout mice; BMDMs; THP-1 cells
Methods:
Flow cytometry; qRT-PCR; RNA sequencing; Western blotting; luciferase reporter assay; immunohistochemistry; antibody-mediated depletion
Genes and proteins analyzed:
HES1; NICD; INOS; STAT6; Arg1; RBPJ; IFNγ; CD4; CD8
Supplementary material:
Figures S1–S10
Contact information:
Department of Biochemistry & Molecular Biology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea; Phone: 82-2-2228-1699; E-mail: [email protected]
Year:
2017
Region / City:
N/A
Topic:
Hematologic Toxicities, Myelodysplastic Syndromes, Acute Myeloid Leukemia
Document Type:
Meta-analysis
Organization:
N/A
Author:
N/A
Target Audience:
Researchers, Healthcare Professionals
Period of Action:
N/A
Approval Date:
N/A
Modification Date:
2/2018
Year:
2019
Region / City:
United Kingdom
Topic:
Cancer, Hematology
Document Type:
Response to Consultation
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
National Institute for Health and Care Excellence (NICE)
Target Audience:
Healthcare professionals, policy makers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
June 2019
Year:
2021
Region / city:
Not specified
Topic:
Mesenchymal cells in bone marrow of AML patients
Document type:
Research Supplementary Data
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, medical professionals
Effective period:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2023
Region / city:
Pittsburgh, PA, U.S.A.
Topic:
Hematology, Oncology, Dermatology
Document type:
Case Report
Institution:
Allegheny General Hospital
Author:
Muhammad Ali Butt, Sameen Aamer, Anastasios Kapetanos
Target audience:
Healthcare professionals, researchers in hematology and oncology
Date of approval:
Not specified
Date of changes:
Not specified
Keywords:
Henoch-Schonlein Purpura, acute myeloid leukemia, cutaneous presentation of acute myeloid leukemia
Abstract:
This document reports an unusual case of Henoch-Schonlein Purpura (HSP) as the presenting symptom of Acute Myeloid Leukemia (AML).
Contextual description:
A case report of a patient who presented with a rash consistent with Henoch-Schonlein Purpura, later diagnosed with Acute Myeloid Leukemia.
Year:
N/A
Region / City:
N/A
Subject:
Immunology
Document Type:
Research Supplement
Organization / Institution:
R&D Systems, ThermoFisher, Biolegend, Invitrogen, eBioscience
Author:
N/A
Target Audience:
Researchers in Immunology
Effective Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Type of Document:
Clinical protocol
Scope:
Myeloid and mixed/ambiguous lineage neoplasms
Applicable Sites:
Bone marrow, blood, cutaneous, extranodal/mucosal, other anatomic sites
Authors:
Robert W. Allan, L. Jeffrey Medeiros, Robert Seifert, Claudio A. Mosse, Samer Z. Al-Quran, Joseph D. Khoury
Issuing Organization:
CAP Cancer and CAP Pathology Electronic Reporting Committees
Version:
1.1.0.0
Protocol Posting Date:
June 2024
Target Audience:
Pathologists and clinicians involved in hematologic malignancy diagnosis
Changes Summary:
Typographical correction in SPECIAL STUDIES section from "interim" to "internal"
Year:
2023
Region / City:
Not specified
Topic:
Leukemia Cutis, Chronic Myeloid Leukemia
Document Type:
Case Report
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Medical professionals, researchers
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
Not specified
Theme:
Hematology, Leukemia, Molecular Biology
Document Type:
Research Supplementary Figure
Author:
Not specified
Target Audience:
Researchers in the field of leukemia and hematopoiesis
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual Description
Year:
2000–2022
Study Type:
Clinical research
Patient Population:
ABL-class leukemia patients
Sample Type:
Bone marrow and blood DNA
Assay Methods:
RNA sequencing, targeted locus amplification (TLA), genomic capture high throughput sequencing (gc-HTS), Fusion Detection by Gene Enrichment (FUDGE), long-range PCR, Sanger sequencing
Quantitative Assay:
MRD Q-PCR based on genomic breakpoints and IG/TR targets
Institution:
Princess Máxima Centrum, Netherlands; USEQ sequencing facility, Utrecht, Netherlands; Macrogen Europe
Ethics:
Written informed consent obtained according to the Declaration of Helsinki
Data Tables:
Supplemental Digital Tables 1–3
Figures:
Supplemental Digital Figures 1–2
Reference Protocols:
EuroMRD guidelines
Year:
2015
Region / City:
Southeastern/Southwest United States
Field:
Medicine, Oncology
Document Type:
Abstract
Organization:
Texas Tech University Health Sciences Center, University of Pennsylvania
Author:
Paul Trippier, Kshitij Verma, Tianzhu Zang, Trevor M. Penning
Target Audience:
Researchers, Medical Professionals
Effective Period:
Not specified
Approval Date:
Not specified
Date of Last Update:
Not specified
Name:
William D. Marrero-León, MD
Current Position:
Clinical Fellow, Leukemia Fellowship Program
Institution:
The University of Texas MD Anderson Cancer Center
Start Date:
July 2025
Specialty:
Hematology and Medical Oncology
Board Certification:
Internal Medicine; Hematology
Clinical Interests:
Targeted therapies; molecular markers in leukemia treatment
Medical School:
Iberoamerican University School of Medicine
Residency:
Internal Medicine, San Juan City Hospital
Previous Appointment:
Faculty Member, University District Hospital
Additional Training:
Fellowship in Hematology and Medical Oncology, San Juan City Hospital
Leadership Role:
Chief Fellow
Awards:
First Prize in Clinical Research (twice), Puerto Rico Hematology Oncology Convention
Research Focus:
Molecular and cytogenetic abnormalities in acute myeloid leukemia (AML) patients in Puerto Rico
Mentor:
Fernando Cabanillas
Publications:
Two peer-reviewed publications
Year:
2017
Region / City:
N/A
Topic:
Hematologic Toxicities, Myelodysplastic Syndromes, Acute Myeloid Leukemia
Document Type:
Meta-analysis
Organization:
N/A
Author:
N/A
Target Audience:
Researchers, Healthcare Professionals
Period of Action:
N/A
Approval Date:
N/A
Modification Date:
2/2018
Year:
2021
Region / city:
Not specified
Topic:
Mesenchymal cells in bone marrow of AML patients
Document type:
Research Supplementary Data
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, medical professionals
Effective period:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2013–2019
Cell Type:
THP-1 acute myeloid leukemia; Jurkat acute lymphoid leukemia
Treatment:
Apigenin (AP), Etoposide (ETP), Cyclophosphamide (CYCLO)
Assay Method:
Proteome ProfilerTM - Human Apoptosis Array
Measured Proteins:
BAD, BAX, BCL2, BCLX, CYT c, SMAC/DIBALO, HTRA2/OMI, TRAILR1/DR4, TNFR1/TNFRSF1A, FAS/D95, FADD, CASP-3
Exposure Time:
24 hours
Effect Type:
Synergistic increase or decrease in apoptosis-related protein expression
Reference Studies:
Mahbub et al., 2013; 2015; 2019
Data Format:
Supplementary Figures
Year:
2010–2015
Institution:
University Hospitals Case Medical Center
Field:
Biomedical Research / Hematology
Document Type:
Research Methods Supplement
Techniques:
Immunohistochemistry, Flow Cytometry, Multi-photon Intravital Imaging, Chromatin Immunoprecipitation, Luciferase Reporter Assay, Western Blot, qRT-PCR
Model Organisms:
Mice (including leukemia models)
Authors:
Myers JT, Barkauskas DS, Huang AY, Wang W, Yu S, Zimmerman G, Wang Y, Yu VW, Huang D, Huang X, Shim J, Huang Y, Xin W, Qiao P, Yan M, Scadden DT, Stanley P, Lowe JB, Zhou L, Yao D
Target Cells:
Hematopoietic stem cells, marrow stromal cells, leukemia cells
Reagents and Antibodies:
Hes1, RBPJ, JAG1, ICN1, ICN2, GFP, Annexin V, CD41, CXCL12, GAPDH
Culture Conditions:
α-MEM medium, serum-free medium, supplements including mSCF and TPO
Imaging Equipment:
SP5/AOBS/2-photon microscope, Leica Microsystems, Imaris software
Analytical Methods:
qRT-PCR, fluorescence imaging, statistical analysis
References:
Myers JT et al., Stem Cells International 2013; Myers J et al., Transfusion 2010; Wang W et al., Stem Cells 2015; Yao D et al., Blood 2011
Year:
2023
Region / City:
Cambridge, Massachusetts; Denver, Colorado; Philadelphia, Pennsylvania
Subject:
Pinometostat treatment, leukemia research, resistance mechanisms
Document Type:
Research Methods Supplement
Author(s):
Carly T. Campbell, Jessica N. Haladyna, David A. Drubin, Ty M. Thomson, Michael J. Maria, Taylor Yamauchi, Nigel J. Waters, Edward J. Olhava, Roy M. Pollock, Jesse J. Smith, Robert A. Copeland, Stephen J. Blakemore, Kathrin M. Bernt, Scott R. Daigle
Target Audience:
Researchers, biotechnologists, and medical professionals in oncology and pharmacology
Period of Validity:
2023
Approval Date:
2023
Modification Date:
N/A
Methodology:
Sanger sequencing, RNA-seq, ChIP-Seq, Quantitative PCR, Western Blot, Transporter Study
Context:
Detailed supplemental methods and experimental procedures for studying resistance mechanisms to Pinometostat in MLL rearranged leukemia cells, including sequencing, immunoprecipitation, and transporter studies.