The Blood and Marrow Transplant Program (BMTP) of the Penn Abramson Cancer Center (ACC) is among the largest and oldest in the nation. This active program sees adults of all ages, sexes and ethnic origins and conducts all forms of hematopoietic cell transplantation (HCT) including autologous, allogeneic (myeloablative and reduced intensity) and cord blood, matched and mismatched including haplo-identical, related and unrelated, and cellular therapies including donor lymphocyte infusions and has been a pioneer in gene modified autologous and allogeneic T cell therapies such as chimeric antigen receptor (CAR) and T cell receptor trials for a myriad of diseases. Dr. Edward Stadtmauer has been the PI of this Core Center since the founding of the Network 15 years ago and is also the Chief, Hematologic Malignancies (HM) Section and Co-Leader of the ACC HM Research Program and so access to patients for BMT CTN clinical trials is straightforward and this has been reflected in the strong accrual from our center. Dr. David Porter works very closely with Dr Stadtmauer and has directed Cellular Immunotherapy for 20 years. 378 patients have been accrued from Penn to BMT CTN; 5th largest of >140 centers participating. Penn has demonstrated intellectual leadership in the Network with membership on 9 protocol teams (study chairs for 4) and chair of 3 administrative and technical committees. Penn investigators were key to the highly successful myeloma series of clinical trials. ACC BMTP remains consistently very active with 799 HCTs conducted in 2013-2015; 536 autologous, 263 allogeneic. The BMTP is supported by numerous world-class ACC research resources including our ACC itself, ranked `Exceptional' as a NCI CCC in 2015, the Center for Cancer Immunotherapy led by our pioneer cellular immunobiologist Dr. Carl June, and the PENN-CHOP Blood Center focused on non-malignant blood disorders run by Charles Abrams a renowned hematologist and current President ASH. Our research proposal, ?A RANDOMIZED PHASE II STUDY OF AUTOLOGOUS HCT FOLLOWED BY anti- BCMA +/- anti-CD19 CAR AUTOLOGOUS T CELLS FOR HIGH-RISK MYELONA.? was chosen among many alternatives from Penn to demonstrate an area of our expertise, based on our own pilot study work, fill a major clinical need (improvement of outcome for patients with high-risk myeloma) and can be completed in a timely fashion. These attributes of strong clinical research, patient care, thought leaders in the field and a documented enthusiasm for and success in BMT CTN trials uniquely position Penn to lead development and evaluation of novel cell therapies and rapidly disseminate results to benefit patients in need of HCT therapy.

Public Health Relevance

Membership as a BMT CTN Core Clinical Center is central to the mission of the University of Pennsylvania Abramson Cancer Center Blood and Marrow Transplant Program (ACC BMTP) to develop and facilitate multidisciplinary, interdepartmental and multi-institutional evaluation of new therapeutic approaches to HCT and to disseminate these findings to health care professionals, the patients and the public to improve the outcome of patients undergoing HCT.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1HL069286-18
Application #
9535451
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Di Fronzo, Nancy L
Project Start
2001-09-30
Project End
2024-06-30
Budget Start
2018-07-01
Budget End
2019-06-30
Support Year
18
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Garfall, Alfred L; Stadtmauer, Edward A; Hwang, Wei-Ting et al. (2018) Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. JCI Insight 3:
D'Souza, Anita; Pasquini, Marcelo; Logan, Brent et al. (2017) Heavy/light chain ratio normalization prior to transplant is of independent prognostic significance in multiple myeloma: a BMT CTN 0102 correlative study. Br J Haematol 178:816-819
Holstein, Sarah A; Jung, Sin-Ho; Richardson, Paul G et al. (2017) Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol 4:e431-e442
Holtan, Shernan G; Verneris, Michael R; Schultz, Kirk R et al. (2015) Circulating angiogenic factors associated with response and survival in patients with acute graft-versus-host disease: results from Blood and Marrow Transplant Clinical Trials Network 0302 and 0802. Biol Blood Marrow Transplant 21:1029-36
Giralt, Sergio; Garderet, Laurent; Durie, Brian et al. (2015) American Society of Blood and Marrow Transplantation, European Society of Blood and Marrow Transplantation, Blood and Marrow Transplant Clinical Trials Network, and International Myeloma Working Group Consensus Conference on Salvage Hematopoietic Cell Tra Biol Blood Marrow Transplant 21:2039-2051
Khera, Nandita; Majhail, Navneet S; Brazauskas, Ruta et al. (2015) Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial. Biol Blood Marrow Transplant 21:1815-22