# BMT Clinical Trial Network at Stanford

> **NIH NIH UG1** · STANFORD UNIVERSITY · 2021 · $143,454

## Abstract

This is a renewal application to RFA-HL-17-018 to propose that Division of Blood and Marrow
Transplantation (BMT) at Stanford University continue as a Core Clinical Center for the BMT
Clinical Trials Network (BMT CTN). Stanford's Program will perform about 380 adult transplants
in 2016 including autologous and allogeneic transplants using cells from matched and
mismatched related and unrelated donors, cord blood units, ex vivo manipulated cell products
and genetically modified cells. Stanford's BMT Program participates in basic, and clinical
research as a single institution, and within regional, national and international consortia. The
division is supported by a National Institutes of Health (NIH) Program Project Grant with over 27
years of funding of basic scientific research, and clinical translational trials that advance the
field. The Program is strengthened by highly experienced biostatics and data management
groups, and a cGMP-compliant, FACT and CLIA certified Cellular Therapy Facility for routine
cell processing and the development of investigational cellular therapies. The Program is a high
accrual BMT CTN center and has enrolled 320 patients to 16 CTN studies. In the past granting
period, Stanford investigators served as Chair of the BMT CTN Steering Committee, Chair to
the Lymphoma Symposium Committee, and have been members on five CTN committees and
one Task Force. Stanford will continue to leverage the capabilities of its Program to support the
research goals of the CTN. It is our collective mission to advance the field of BMT for patients
with rare and difficult to treat blood diseases through high quality multi-center clinical trials. The
goal of the proposed protocol in the current application is to determine if a novel strategy can
reduce the risk of developing chronic GVHD (cGVHD) and thereby improve upon traditional
allogeneic BMT. We propose a randomized phase 3 clinical trial where the active comparator is
Ibrutinib starting 90 days after transplant and the control arm is no additional cGVHD prevention
strategy. This study builds upon our prior preclinical and clinical work with this agent for the
treatment and prevention of cGVHD. The primary outcome measure will be the rate of steroid
requiring cGVHD by 18 months after transplant. Based on an aggregate of data, we
hypothesize that Ibrutinib will reduce cGVHD development due to its ability to block B cell
activation via irreversible inhibition of Bruton's tyrosine kinase (BTK) and its ability to block T
helper subset activation from inhibition of IL-2 inducible T cell kinase (ITK). The Stanford BMT
program is committed to continued participation in BMT CTN trials, contributing concepts for
consideration by the Network, and participating in Network committees and citizenship activities.
!

## Key facts

- **NIH application ID:** 10187627
- **Project number:** 5UG1HL069291-21
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Robert Lowsky
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $143,454
- **Award type:** 5
- **Project period:** 2001-09-30 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10187627

## Citation

> US National Institutes of Health, RePORTER application 10187627, BMT Clinical Trial Network at Stanford (5UG1HL069291-21). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10187627. Licensed CC0.

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