Relevant bibliographies by topics / Surrogate endpoint, Validation, Leukemia

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  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Conference papers

Academic literature on the topic 'Surrogate endpoint, Validation, Leukemia'

Author: Grafiati
Published: 9 March 2023
Last updated: 31 July 2025

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Journal articles on the topic "Surrogate endpoint, Validation, Leukemia"

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Valsecchi, Maria Grazia, Meenakshi Devidas, Ausiliatrice Lucenti, et al. "Evaluation of Minimal Residual Disease As a Surrogate Endpoint for Event Free Survival in Childhood B-Lineage Acute Lymphoblastic Leukemia." Blood 128, no. 22 (2016): 759. http://dx.doi.org/10.1182/blood.v128.22.759.759.

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Abstract Introduction The need to optimize clinical evaluation of new drugs stimulates researchers and regulatory bodies to consider novel endpoints that facilitate assessment of the efficacy of a new drug earlier in time than do traditional endpoints. To be a useful marker of efficacy, an early endpoint must be an accurate surrogate for the true clinical endpoint. Minimal residual disease (MRD) is a strong prognostic factor for Event Free Survival (EFS) in children with newly diagnosed acute lymphoblastic leukemia (ALL) and is used routinely to assess treatment response and stratify treatment
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Wang, Lin, Tim Disher, Fei Fei Liu, et al. "Evaluating CR as a surrogate endpoint for PFS in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): A meta-analysis of randomized controlled trials (RCT)." Journal of Clinical Oncology 42, no. 16_suppl (2024): 7046. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.7046.

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7046 Background: CLL/SLL is the most common leukemia in adults. Achieving a CR by International Workshop on CLL 2018 criteria indicates complete eradication of CLL/SLL in all disease compartments. Patients with R/R CLL/SLL who achieved CR tend to have delayed disease progression/death compared with patients who did not achieve CR. This is the first report to evaluate CR as a surrogate endpoint for PFS in R/R CLL/SLL using aggregate RCT data. Methods: A systematic literature review (SLR) identified published RCTs in R/R CLL/SLL from inception to 10/2023, reporting nonzero CR rates (CRR) and PFS
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Gonneau, Christele, Marc Brugarolas, Lotje Van Haecht, et al. "Validation and Implementation of Flow Cytometry Based Minimal Residual Disease (MRD) Assay for Chronic Lymphocytic Leukemia (CLL) Clinical Studies." Blood 144, Supplement 1 (2024): 6761. https://doi.org/10.1182/blood-2024-206125.

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Background: With the advances made in novel anti-cancer therapies, Chronic Lymphocytic Leukemia (CLL) patient remission rates have significantly improved over the years. Minimal or measurable residual disease (MRD) is emerging as an independent predictor of progression-free survival (PFS) and overall survival (OS) in several heme indications and has been proposed as a potential surrogate endpoint for long term CLL survival in clinical trials. While next generation sequencing (NGS) methods are emerging for establishing MRD measurements in CLL, flow cytometry remains as an option of choice for m
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Hjelmgren, Jonas, Kristoffer Nilsson, and Gunnar Birgegård. "JAK2 V617F as a Marker for Long-Term Disease Progression and Mortality in Polycythemia Vera and its Role in Economic Modeling." Journal of Health Economics and Outcomes Research 7, no. 1 (2020): 61–70. http://dx.doi.org/10.36469/jheor.2020.13083.

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Background: In order to facilitate sound economic evaluations of novel treatments, health-economic models of polycythemia vera (PV) must combine effects on surrogate endpoints in trials with disease progression (DP) and mortality in long-term cohort data. Objective: We validate an economic model for PV that uses Janus Kinase 2 (JAK2) burden as a surrogate endpoint to predict DP (thrombosis, myelofibrosis, and acute leukemia) and overall survival (OS) based on progression-specific mortality. Methods: Long-term observational studies that include information about baseline JAK2 burden were identi
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Yin, Jun, Geoffrey L. Uy, Betsy Laplant, et al. "Event-Free Survival As a Surrogate Endpoint for Overall Survival in Previously Untreated Acute Myeloid Leukemia: An Individual Patient-Level Analysis of Multiple Randomized Trials (Alliance A151614)." Blood 132, Supplement 1 (2018): 1386. http://dx.doi.org/10.1182/blood-2018-99-113902.

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Abstract Background: Overall survival (OS) remains the definitive primary efficacy endpoint to evaluate previously untreated acute myeloid leukemia (AML) therapies, but it requires prolonged follow-up. An earlier endpoint assessed post-treatment would expedite clinical trial conduct and accelerate patient access to effective new therapies. Our objective was to formally evaluate event-free survival (EFS) as a surrogate endpoint for OS in untreated AML. Methods: Individual patient data were analyzed from 2,475 patients (pts) from 4 multicenter, randomized controlled phase III trials of active tr
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Schilhabel, Anke, Henrik Knecht, Anton W. Langerak, et al. "Analytical Validation of Patient-Specific PCR-Based MRD Assessment for Use As a Primary Endpoint in CLL Clinical Trials." Blood 126, no. 23 (2015): 2924. http://dx.doi.org/10.1182/blood.v126.23.2924.2924.

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Abstract Introduction. Minimal residual disease (MRD) is an objective measure of disease status defined by the number of leukemic cells in the blood or bone marrow of leukemic patients. In recent clinical studies of chronic lymphocytic leukemia (CLL), undetectable MRD levels (< 1 tumor cell/10,000 leukocytes) have been shown to correlate with prolonged progression free survival (PFS) and overall survival, independent of treatment or known risk factors. MRD assessment has been proposed as an alternative to PFS as a primary endpoint in frontline CLL pivotal studies to evaluate the efficacy of
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Dimier, Natalie, Paul Delmar, Carol Ward, et al. "A Model for Predicting Effect of Treatment on Progression-Free Survival Using Minimal Residual Disease As a Surrogate Endpoint in Chronic Lymphocytic Leukemia." Blood 126, no. 23 (2015): 720. http://dx.doi.org/10.1182/blood.v126.23.720.720.

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Abstract Introduction The standard primary endpoint in clinical trials of chronic lymphocytic leukemia (CLL) is progression-free survival (PFS). Given the increasingly long follow up required to detect differences in PFS between treatment arms in the era of more efficient therapeutics, valid surrogate endpoints are urgently needed to reduce clinical trial duration, thereby accelerating drug development, reducing costs and allowing patients (pts) earlier access to novel treatment options. Pts with CLL who achieve levels of minimal residual disease (MRD) of <1 clonal cell/10.000 leukocytes in
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Wang, Xiaofei, Xiaoyi Wang, Lydia Hodgson, et al. "Validation of Progression‐Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials." Oncologist 22, no. 2 (2017): 189–98. http://dx.doi.org/10.1634/theoncologist.2016-0121.

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Kaur, Pavinder, Anil Pahuja, Kevin Nguyen, et al. "Best Practices for Validation of Measurable Residual Disease Assessments By Multiparameter Flow Cytometry in Emerging Clinical Trials of Acute Myeloid Leukemia." Blood 136, Supplement 1 (2020): 22–23. http://dx.doi.org/10.1182/blood-2020-137787.

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Background: Measurable Residual Disease (MRD) assessments are gaining increasing acceptance as a prognostic factor for tailoring treatment in hematological malignancies. Acute Myeloid Leukemia (AML) is a heterogeneous disease with high relapse rates and presents a high unmet need for effective treatment options. Measurement of residual disease after therapy reflects a combination of all resistance mechanisms and is currently used for guiding treatment options. Study Design: In this study, we aimed to validate an AML-MRD assay by multiparameter flow cytometry (MFC) methodology. This is a 4-tube
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Bahar, N., L. Mohseninejad, K. McDonald, and T. Wilke. "A META‐ANALYTIC ENDPOINT VALIDATION OF SURROGATES USED IN CLINICAL TRIALS EVALUATING THE EFFICACY OF THERAPIES IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)." Hematological Oncology 41, S2 (2023): 743–44. http://dx.doi.org/10.1002/hon.3165_594.

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Dissertations / Theses on the topic "Surrogate endpoint, Validation, Leukemia"

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LUCENTI, AUSILIATRICE. "The Validation of Candidate Surrogates for a Time to Event Endpoint in Childhood Leukemia." Doctoral thesis, Università degli Studi di Milano-Bicocca, 2016. http://hdl.handle.net/10281/105006.

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The selection of the primary “endpoint” is a very important step in the design of clinical trials. Typically, the goal of a clinical trial is to assess the effect of treatment on this endpoint. It often happens, that the most sensitive and relevant clinical endpoint, which will be called the “true” endpoint, might be difficult to assess and to overcome this problem, a solution is to replace the true endpoint with another one, which is measured earlier, more conveniently or more frequently. Such “replacement” endpoint is termed “surrogate” and has the purpose of evaluating the effect of a speci
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Book chapters on the topic "Surrogate endpoint, Validation, Leukemia"

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Molenberghs, Geert, Marc Buyse, and Tomasz Burzykowski. "The History of Surrogate Endpoint Validation." In Statistics for Biology and Health. Springer New York, 2005. http://dx.doi.org/10.1007/0-387-27080-9_5.

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Burzykowski, Tomasz, and Marc Buyse. "An Alternative Measure for Meta-analytic Surrogate Endpoint Validation." In Statistics for Biology and Health. Springer New York, 2005. http://dx.doi.org/10.1007/0-387-27080-9_18.

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Conference papers on the topic "Surrogate endpoint, Validation, Leukemia"

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Gabler, Nicole B., Benjamin French, Brian L. Strom, et al. "Validation Of Six-Minute-Walk Distance As A Surrogate Endpoint In Pulmonary Arterial Hypertension Trials." In American Thoracic Society 2012 International Conference, May 18-23, 2012 • San Francisco, California. American Thoracic Society, 2012. http://dx.doi.org/10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a4092.

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Journal articles
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