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Aiesha Zia

ORCID: 0009-0009-1767-6078
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A5068801125
Research Areas
  • CAR-T cell therapy research
  • Lymphoma Diagnosis and Treatment
  • Immunotherapy and Immune Responses
  • Virus-based gene therapy research
  • Immune Cell Function and Interaction
  • Acute Lymphoblastic Leukemia research
  • Health Systems, Economic Evaluations, Quality of Life
  • CNS Lymphoma Diagnosis and Treatment
  • Statistical Methods in Clinical Trials
  • Advanced Causal Inference Techniques
  • Chronic Lymphocytic Leukemia Research
  • Biomedical Ethics and Regulation
  • Myeloproliferative Neoplasms: Diagnosis and Treatment
  • Hemoglobinopathies and Related Disorders
  • RNA Interference and Gene Delivery
  • Cancer Genomics and Diagnostics
  • Biosimilars and Bioanalytical Methods
  • Blood groups and transfusion
  • Viral Infectious Diseases and Gene Expression in Insects
  • Integrated Circuits and Semiconductor Failure Analysis
  • CRISPR and Genetic Engineering
  • Monoclonal and Polyclonal Antibodies Research

Novartis (Switzerland)
 2018-2024

National Cancer Institute
 2023

 Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial
OPENALEX - Publications 
Nathan Fowler Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 30 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Rakesh Awasthi Aisha Masood Oezlem Anak Stephen J. Schuster Catherine Thiéblemont

10.1038/s41591-021-01622-0 article EN Nature Medicine 2021-12-17
 Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update
OPENALEX - Publications 
Martin Dreyling Nathan Fowler Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 35 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Inès Paule Aiesha Zia Rakesh Awasthi Xia Han Davide Germano Darragh O’Donovan Roberto Ramos Harald J. Maier Aisha Masood Catherine Thiéblemont Stephen J. Schuster

Tisagenlecleucel is approved for adults with relapsed/refractory (r/r) follicular lymphoma (FL) in the third- or later-line setting. The primary analysis (median follow-up, 17 months) of phase 2 ELARA trial reported high response rates and excellent safety profile patients extensively pretreated r/r FL. Here, we report longer-term efficacy, safety, pharmacokinetic, exploratory biomarker analyses after median follow-up 29 months (interquartile range, 22.2-37.7). As March 2022, 97 FL (grades...

10.1182/blood.2023021567 article EN cc-by-nc-nd Blood 2024-01-09
 Long-Term Clinical Outcomes and Correlative Efficacy Analyses in Patients (Pts) with Relapsed/Refractory Follicular Lymphoma (r/r FL) Treated with Tisagenlecleucel in the Elara Trial
OPENALEX - Publications 
Martin Dreyling Michael Dickinson Joaquín Martínez‐López Arne Kolstad Jason Butler and 34 more Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Phoebe Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Inès Paule Aiesha Zia Rakesh Awasthi Xia Han Davide Germano Darragh O’Donovan Roberto Ramos Aisha Masood Catherine Thiéblemont Nathan Fowler Stephen J. Schuster

10.1182/blood-2022-158024 article EN Blood 2022-11-15
 Combining the Target Trial and Estimand Frameworks to Define the Causal Estimand: An Application Using Real-World Data to Contextualize a Single-Arm Trial
OPENALEX - Publications 
Lisa V. Hampson Jufen Chu Aiesha Zia Jie Zhang Wei‐Chun Hsu and 3 more Craig S. Parzynski Yanni Hao Evgeny Degtyarev

Single-arm trials (SATs) may be used to support regulatory submissions in settings where there is a high unmet medical need and highly promising early efficacy data undermine the equipoise needed for randomization. In this context, patient-level real-world (RWD) create an external control arm (ECA) contextualize SAT results. However, naive comparisons of with its ECA will yield biased estimates causal effects if groups are imbalanced regards (un)measured prognostic factors. Several methods...

10.1080/19466315.2023.2190931 article EN Statistics in Biopharmaceutical Research 2023-03-15
 Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 Elara Trial
OPENALEX - Publications 
Nathan Fowler Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 29 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Sarah Nagle Loretta J. Nastoupil Bastian von Tresckow Andrés JM Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Lida Pacaud Alessandra Forcina Aiesha Zia Stephen J. Schuster Catherine Thiéblemont

10.1182/blood-2020-138983 article EN Blood 2020-11-04
 Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias
OPENALEX - Publications 
Alì Taher Raffaella Origa Silverio Perrotta Alexandra Kouraklis Giovan Battista Ruffo and 6 more Antonis Kattamis Ai‐Sim Goh Vicky Huang Aiesha Zia Raquel Herranz John B. Porter

Adherence to long-term chelation therapy in transfusion-dependent patients is critical prevent iron overload-related complications. Once-daily deferasirox dispersible tablets (DT) have proven efficacy and safety ≥2 years old with chronic transfusional overload. However, barriers optimal adherence remain, including palatability, preparation time, requirements for fasting state. A new film-coated tablet (FCT) formulation was developed, swallowed once daily (whole/crushed) with/without a light...

10.1186/s12955-018-1041-5 article EN cc-by Health and Quality of Life Outcomes 2018-11-19
 Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up
OPENALEX - Publications 
Stephen J. Schuster Nathan Fowler Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 32 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Phoebe Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Rakesh Awasthi Inès Paule Davide Germano Roberto Ramos Pei Hsu Catherine Thiéblemont Martin Dreyling

10.1182/blood-2023-180936 article EN Blood 2023-11-02
 Efficacy and safety of tisagenlecleucel (Tisa-cel) in adult patients (Pts) with relapsed/refractory follicular lymphoma (r/r FL): Primary analysis of the phase 2 Elara trial.
OPENALEX - Publications 
Stephen J. Schuster Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 15 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Ahmed M. Abdelhady Aiesha Zia Mony Chenda Morisse Nathan Fowler Catherine Thiéblemont

7508 Background: Most pts with r/r FL experience multiple relapses and progressively worse clinical outcomes each line of therapy, underlining a need for novel therapies. Tisa-cel has demonstrated durable responses manageable safety in adult diffuse large B-cell lymphoma. Here we report the primary analysis ELARA, an international, single-arm phase 2 trial tisa-cel FL. Methods: Eligible (≥18 y) had (grades [Gr] 1-3A) after ≥2 lines therapy or failed autologous stem cell transplant. Bridging...

10.1200/jco.2021.39.15_suppl.7508 article EN Journal of Clinical Oncology 2021-05-20
 Efficacy of Tisagenlecleucel in Adult Patients (Pts) with High-Risk Relapsed/Refractory Follicular Lymphoma (r/r FL): Subgroup Analysis of the Phase II Elara Study
OPENALEX - Publications 
Catherine Thiéblemont Michael Dickinson Joaquín Martínez‐López Arne Kolstad Jason Butler and 29 more Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés JM Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Chiara Lobetti Bodoni Aisha Masood Stephen J. Schuster Nathan Fowler Martin Dreyling

10.1182/blood-2021-145025 article EN Blood 2021-11-05
 Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up
OPENALEX - Publications 
Stephen J. Schuster Nathan Fowler Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 32 more Jason M. Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Rakesh Awasthi Inès Paule Davide Germano Roberto Ramos Pei Hsu Catherine Thieblemont Martin Dreyling

10.1016/j.jtct.2023.12.068 article EN cc-by-nc-nd Transplantation and Cellular Therapy 2024-02-01
 Clinical Outcomes of Patients with High-Risk Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 ELARA 4-Year Update
OPENALEX - Publications 
Catherine Thieblemont Martin Dreyling Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 30 more Jason M. Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Phoebe Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Rakesh Awasthi Davide Germano Roberto Ramos Pei Hsu Stephen J. Schuster Nathan Fowler

10.1182/blood-2024-201730 article EN Blood 2024-11-05
 EFFICACY AND SAFETY OF TISAGENLECLEUCEL (TISA‐CEL) IN ADULT PATIENTS (PTS) WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (R/R FL): PRIMARY ANALYSIS OF THE PHASE 2 ELARA TRIAL
OPENALEX - Publications 
Stephen J. Schuster Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 15 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae M. J. Kersten Charalambos Andreadis Peter A. Riedell Ahmed M. Abdelhady Aiesha Zia Mony Chenda Morisse Nathan Fowler Catherine Thiéblemont

Introduction: Most pts with r/r FL experience multiple relapses and progressively worse clinical outcomes each line of therapy, underlining a need for novel therapies. Tisa-cel has demonstrated durable responses manageable safety in adult diffuse large B-cell lymphoma. Here we report the primary analysis ELARA (NCT03568461), an international, single-arm phase 2 trial tisa-cel FL. Methods: Eligible (≥18 y) had (grades [Gr] 1-3A) after ≥2 lines therapy or failed autologous stem cell...

10.1002/hon.85_2879 article EN Hematological Oncology 2021-06-01
 Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 Elara Trial
OPENALEX - Publications 
Nathan Fowler Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 29 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Sarah Nagle Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Lida Pacaud Alessandra Forcina Aiesha Zia Stephen J. Schuster Catherine Thiéblemont

10.1016/s2666-6367(21)00104-4 article EN cc-by-nc-nd Transplantation and Cellular Therapy 2021-01-31
 Clinical Outcomes of Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Treated With Tisagenlecleucel: Phase 2 ELARA 3-Year Follow- Up
OPENALEX - Publications 
Stephen J. Schuster Nathan Fowler Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 32 more Jason M. Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Rakesh Awasthi Inès Paule Davide Germano Roberto Ramos Pei Hsu Catherine Thieblemont Martin Dreyling

10.1016/s2152-2650(24)00855-3 article EN Clinical Lymphoma Myeloma & Leukemia 2024-08-26
 IBCL-271 Clinical Outcomes of Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Treated With Tisagenlecleucel: Phase 2 ELARA 3-Year Follow-Up
OPENALEX - Publications 
Stephen J. Schuster Nathan Fowler Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 32 more Jason M. Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Petzer Pier E.M. Patten Ram Malladi Aiesha Zia Rakesh Awasthi Inès Paule Davide Germano Roberto Ramos Pei Hsu Catherine Thieblemont Martin z-Lopez

10.1016/s2152-2650(24)01561-1 article EN Clinical Lymphoma Myeloma & Leukemia 2024-08-26
 Efficacy and Safety of Tisagenlecleucel in Patients with Relapsed/Refractory Follicular Lymphoma: A Real-World Analysis from the Center for Blood and Marrow Transplant Research (CIBMTR) Registry
OPENALEX - Publications 
Daniel J. Landsburg Richard T. Maziarz Amy Moskop Leslie Popplewell Scott R. Solomon and 7 more Michael Tees Yang Yang Aiesha Zia Stephen Lim Avishek Pal Pei Hsu Frederick L. Locke

10.1182/blood-2024-204207 article EN Blood 2024-11-05
 Rapcabtagene Autoleucel (YTB323) in Patients (Pts) with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): Phase II Trial Clinical Update
OPENALEX - Publications 
Peter A. Riedell Mi Kwon Ian W. Flinn Michael Dickinson Carlos Solano and 17 more Ulrich Jaeger Javier Briones Koji Kato Shaun Fleming Emmanuel Bachy Alessandro Rambaldi Leyla Shune Nirav N. Shah Didier Blaise Matthew J. Frigault Aravind Ramakrishnan Anne Yang David Pearson Aiesha Zia Eduardo Segura Aisha Masood Pere Barba

10.1182/blood-2024-204264 article EN Blood 2024-11-05
 CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)
OPENALEX - Publications 
Nathan Fowler Martin Dreyling Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 34 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Inès Paule Aiesha Zia Rakesh Awasthi Xia Han Davide Germano Darragh O’Donovan Roberto Ramos Aisha Masood Catherine Thiéblemont Stephen J. Schuster

10.1016/s2152-2650(23)01523-9 article EN Clinical Lymphoma Myeloma & Leukemia 2023-08-31
 CT-526 Updated Results From a Rapcabtagene Autoleucel (YTB323) Phase I Study Demonstrate Durable Efficacy and a Manageable Safety Profile in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
OPENALEX - Publications 
Nirav N. Shah Ian W. Flinn Mi Kwon Ulrich Jäger Javier Briones and 18 more Emmanuel Bachy Didier Blaise Nicolas Boissel Koji Kato Peter A. Riedell Matthew J. Frigault Leyla Shune Takanori Teshima Fabio Ciceri Shaun Fleming Silvia Ferrari David Pearson Jeanne Whalen Aiesha Zia Jaclyn Davis Aisha Masood Michael Dickinson Pere Barba

10.1016/s2152-2650(23)01520-3 article EN Clinical Lymphoma Myeloma & Leukemia 2023-08-31
 IBCL-195: Primary Analysis of the Phase 2 ELARA Trial: Tisagenlecleucel Efficacy and Safety in Adult Patients with Relapsed/Refractory Follicular Lymphoma (r/r FL)
OPENALEX - Publications 
Stephen J. Schuster Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 14 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Aiesha Zia Mony Chenda Morisse Nathan Fowler Catherine Thiéblemont

10.1016/s2152-2650(21)01911-x article EN Clinical Lymphoma Myeloma & Leukemia 2021-08-30
 Poster: IBCL-195: Primary Analysis of the Phase 2 ELARA Trial: Tisagenlecleucel Efficacy and Safety in Adult Patients with Relapsed/Refractory Follicular Lymphoma (r/r FL)
OPENALEX - Publications 
Stephen J. Schuster Michael Dickinson Martin Dreyling Joaquín Martínez‐López Arne Kolstad and 14 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell Aiesha Zia Mony Chenda Morisse Nathan Fowler Catherine Thiéblemont

10.1016/s2152-2650(21)01539-1 article EN Clinical Lymphoma Myeloma & Leukemia 2021-08-30
 POSTER: CT-526 Updated Results From a Rapcabtagene Autoleucel (YTB323) Phase I Study Demonstrate Durable Efficacy and a Manageable Safety Profile in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
OPENALEX - Publications 
Nirav N. Shah Ian W. Flinn Mi Kwon Ulrich Jäger Javier Briones and 18 more Emmanuel Bachy Didier Blaise Nicolas Boissel Koji Kato Peter A. Riedell Matthew J. Frigault Leyla Shune Takanori Teshima Fabio Ciceri Shaun Fleming Silvia Ferrari David Pearson Jeanne Whalen Aiesha Zia Jaclyn Davis Aisha Masood Michael Dickinson Pere Barba

10.1016/s2152-2650(23)00925-4 article EN Clinical Lymphoma Myeloma & Leukemia 2023-08-31
 POSTER: CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)
OPENALEX - Publications 
Nathan Fowler Martin Dreyling Michael Dickinson Joaquín Martínez‐López Arne Kolstad and 34 more Jason Butler Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P. Joy Ho Jose Antonio Pérez‐Simón Andy Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Inès Paule Aiesha Zia Rakesh Awasthi Xia Han Davide Germano Darragh O’Donovan Roberto Ramos Aisha Masood Catherine Thiéblemont Stephen J. Schuster

10.1016/s2152-2650(23)00911-4 article EN Clinical Lymphoma Myeloma & Leukemia 2023-08-31
 Efficacy of Tisagenlecleucel in Adult Patients (Pts) with High Risk Relapsed/Refractory Follicular Lymphoma (r/r FL): Subgroup Analysis of the Phase 2 Elara Study
OPENALEX - Publications 
Catherine Thieblemont Michael Dickinson Joaquín Martínez‐López Arne Kolstad Jason M. Butler and 29 more Monalisa Ghosh Leslie Popplewell Julio C. Chávez Emmanuel Bachy Koji Kato Hideo Harigae Marie José Kersten Charalambos Andreadis Peter A. Riedell P Joy Ho Jose Antonio Pérez‐Simón Andy I. Chen Loretta J. Nastoupil Bastian von Tresckow Andrés J.M. Ferreri Takanori Teshima Piers Patten Joseph P. McGuirk Andreas Petzer Fritz Offner Andreas Viardot Pier Luigi Zinzani Ram Malladi Aiesha Zia Chiara Lobetti Bodoni Aisha Masood Stephen J. Schuster Nathan Fowler Martin Dreyling

10.1016/s2666-6367(22)00235-4 article EN cc-by-nc-nd Transplantation and Cellular Therapy 2022-03-01
 Combining the target trial and estimand frameworks to define the causal estimand: an application using real-world data to contextualize a single-arm trial
OPENALEX - Publications 
Lisa V. Hampson Jufen Chu Aiesha Zia Jie Zhang Wei-Chun Hsu and 3 more Craig S. Parzynski Yanni Hao Evgeny Degtyarev

Single-arm trials (SATs) may be used to support regulatory submissions in settings where there is a high unmet medical need and highly promising early efficacy data undermine the equipoise needed for randomization. In this context, patient-level real-world (RWD) create an external control arm (ECA) contextualize SAT results. However, naive comparisons of with its ECA will yield biased estimates causal effects if groups are imbalanced regards (un)measured prognostic factors. Several methods...

10.48550/arxiv.2202.11968 preprint EN cc-by-nc-sa arXiv (Cornell University) 2022-01-01
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