# Biostatistics and Data Management

> **NIH NIH P01** · DANA-FARBER CANCER INST · 2020 · $288,360

## Abstract

Project Summary
Allogeneic hematopoietic stem cell transplantation (HSCT) is a long-established therapy for blood malignancies.
The therapeutic benefit and potential cure achieved by HSCT is mediated by the graft-vs-tumor (GVT) effect that
is derived from donor immune system. The overarching objective of the research projects in this Program Project
application is thus to enhance this GVL effect for high risk patients for relapse by administering subsequent
immunomodulation with the goal of developing novel strategies for selectively enhancing tumor immunity and
improving patient outcomes. Specifically, Project 1 will focus on clinical trials for novel immunotherapies that are
designed to enhance post-transplant immune reactivity pre-emptively using whole leukemia cell vaccination,
neoantigen/minor histocompatibility antigens (mHAgs) vaccination or check point blockade inhibitor or to treat
relapse using Treg depleted donor lymphocyte infusion plus check point blockade inhibitor. Project 2 will
investigate the underlying mechanisms of GVL and the specific T cell responses to neoantigen/mHAgs
vaccination generated in clinical trials carried out in Project 1. Project 3 will focus on the impact of clonal
hematopoiesis (CHIP) in the donor stem cell product on clinical and immunologic outcomes after transplant. The
primary objective of the Biostatistics and Data Management Core (Core 1) is to provide statistical collaboration
for all investigators involved in this Program Project. This includes collaboration with project investigators in the
design of clinical trials in Project 1 and laboratory studies in Projects 2 and 3, analysis of clinical and laboratory
data and to establish correlations of clinical outcomes with laboratory results in Projects 1-3, and participate in
manuscript writing in all Projects. Core 1 will also provide centralized mechanisms to assure the timely and
complete capture of all clinical data in this Program Project. This includes collection and maintenance of
necessary clinical information, data management support, quality control for clinical data, and oversight of clinical
trial operations to ensure that all data elements required by each protocol are collected in timely fashion; and
where necessary, design of research procedures and databases to allow blinded laboratory assessments and
later integration with patient-level data for analysis.
PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

## Key facts

- **NIH application ID:** 9995451
- **Project number:** 5P01CA229092-02
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** Haesook T Kim
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $288,360
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9995451

## Citation

> US National Institutes of Health, RePORTER application 9995451, Biostatistics and Data Management (5P01CA229092-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9995451. Licensed CC0.

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