Registration for the Data Studio Office Hour is not available on this occasion because the slots have been reserved. Given that this is our first meeting for the Spring Quarter, we will review the syllabus for Data Studio (BIODS 232) with the enrolled students and present a brief introductory lecture from 1:30 until 2:00 PM. We have investigators registered for Office Hour consultations from 2:00 until 3:00 PM. You are welcome to observe the session.
Abstract (PDF)
Zoom Access
TIME: 1:30–3:00 PM
INVESTIGATORS:
Theresa Lii (1)
Boris Heifets (1)
(1) Anesthesiology, Perioperative, and Pain Medicine
LOCATION: Conference Room X303, Medical School Office Building, 1265 Welch Road, Stanford, CA
WEBPAGE: https://dbds.stanford.edu/data-studio/
ABSTRACT:
The Data Studio Workshop brings together a biomedical investigator with a group of experts for an in-depth session to solicit advice about statistical and study design issues that arise while planning or conducting a research project. This week, the investigator(s) will discuss the following project with the group.
This is a single-site, double-blinded RCT to evaluate the antidepressant superiority of IV ketamine compared to placebo, when administered during surgery (while under anesthesia) to adult patients with symptomatic major depressive disorder.
Participants were randomly allocated in a 1:1 ratio to one of two groups: the intervention group (n=20) received a single administration of IV ketamine during surgery; the placebo group (n=20) received IV saline during surgery. The study drug was given after anesthetic induction to ensure participant blinding. Healthcare providers, investigators, and outcomes assessors were also blinded.
Our primary outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS), which is widely used in depression trials. Baseline MADRS scores were obtained during screening and immediately prior to surgery. MADRS scores were also collected on postoperative days 1, 2, 3, 5, 7, and 14. Secondary outcomes include the Hospital Anxiety and Depression Scale (HADS), pain scores, opioid use, and hospital length of stay.
Our pre-specified analysis method uses linear mixed modeling (specifically MMRM) using the following timepoints: day 0 (baseline), and postoperative days 1, 2 and 3.
STATISTICAL ISSUES
This study has completed enrollment, randomization, and collection of all pre-specified outcomes.
TIME: 1:30–3:00 PM
LOCATION: Conference Room X303, Medical School Office Building, 1265 Welch Road, Stanford, CA
REGISTRATION FORM: https://redcap.stanford.edu/surveys/?s=WMH74XCX33
DESCRIPTION:
The Data Studio Office Hour brings together a series of biomedical investigators with a group of experts for brief individualized sessions to solicit advice about a statistical and study design issue that arises while planning or conducting a research project.
This week, Data Studio holds office hours for your data science needs. Biomedical Data Science faculty are available to provide assistance with your research questions. If you need help with bioinformatics software and pipelines, check out the Computational Services and Bioinformatics Facility (http://cmgm-new.stanford.edu/) and the Genetics Bioinformatics Service Center (http://med.stanford.edu/gbsc.html).
Reserve a Data Studio Office Hour session by completing the Registration Form. Sessions are about 30 minutes long but might be extended at the discretion of the coordinator. If you register for a session, please be present at the start time on Wednesday.
If you are not able to register for a session, you are welcome to complete our Data Studio Consultation services form for a free one-hour meeting with one of our statisticians. You will find a link to the Consultation services form on our Data Studio web page (https://dbds.stanford.edu/data-studio/).
TITLE: Impact of CAR T-Cell Expansion in the First 28 Days on Clinical Outcomes
TIME: 1:30–3:00 PM
LOCATION: Conference Room X303, Medical School Office Building, 1265 Welch Road, Stanford, CA
INVESTIGATORS:
Mark P. Hamilton (1)
Matt Frank (1,2)
David Miklos (1,2)
WEBPAGE: https://dbds.stanford.edu/data-studio/
ABSTRACT
The Data Studio Workshop brings together a biomedical investigator with a group of experts for an in-depth session to solicit advice about statistical and study design issues that arise while planning or conducting a research project. This week, the investigator(s) will discuss the following project with the group.
INTRODUCTION
Chimeric antigen receptor (CAR) T-cell therapy is a new therapy that is increasingly used as second- and third-line treatment of relapsed and refractory aggressive and indolent lymphoma. CAR T-cells expand rapidly in vivo in the first 14 days post-infusion and then retract. Persistent CAR T-cells can be detected for up to 10 years post-treatment. There is limited preliminary data indicating CAR T-cell expansion is associated with increased CAR-related toxicity such as cytokine release syndrome (CRS) and immune-effector-cell-associated neurotoxicity syndrome (ICANS). Similarly, there is limited data indicating CAR expansion may be associated with survival response.
HYPOTHESIS & AIM
Assessment of clinical outcomes associated with CAR T-cell expansion will represent a major advance in understanding clinical CAR T-cell function. We hypothesize that CAR T-cell expansion is associated with clinical endpoints of toxicity and survival response. The first purpose of this project is to understand the impact of CAR T-cell expansion on toxicity and survival outcomes that include: maximal CRS, maximal ICANS, duration of post-treatment neutropenia, and progression free survival.
DATASET
This study is the largest analysis of clinical CAR T-cell expansion data using commercial products to date. We followed 230 patients treated with axicabtagene ciloleucel (axi-cel) or brexucabtagene autoleucel (brexu-cel) over five years, including 189 patients treated for large B-cell lymphoma (LBCL), 20 patients treated for follicular lymphoma (FL) and 21 patients treated for mantle cell lymphoma (MCL). We used flow cytometric phenotyping of CAR T-cells (CAR-FACS) to define CAR T-cell expansion in blood in the majority of patients. CAR-FACS was performed on days 7 (D7), 14 (D14), 21 (D21), and 28 (D28). At least two CAR expansion measurements were available for 140 LBCL patients, 20 FL patients and 18 MCL patients for a total of 640 measurements. Numerous pre- and post-treatment parameters are assessed for each patient including both categorical and continuous variables. A limited number of variables are shared and interpretable between the LBCL, MCL, and FL histologies.
STATISTICAL MODELS
We hope to build two models of survival after CAR in our LBCL patient population where mature survival data exists (at least six months of follow up). First, we would like to leverage the dataset to perform an unbiased analysis of factors associated with CAR T-cell outcomes. Second, we would like to focus on CAR T-cell expansion metrics on D7 and D14 as a possible early indicator of CAR T-cell expansion failure. This is clinically relevant because CAR patients with poor early expansion and worse expected outcomes could receive second infusions, or move on to an allogeneic CAR T-cell therapy.
STATISTICAL QUESTIONS