Guidance for Developing Phase II Cell Therapy Trial Proposals for Consideration by the Blood and Marrow Transplant Clinical Trials Network

Edwin M. Horwitz; Mary M. Horowitz; Nancy L. DiFronzo; Donald B. Kohn; Helen E. Heslop

doi:10.1016/j.bbmt.2010.08.020

Guidance for Developing Phase II Cell Therapy Trial Proposals for Consideration by the Blood and Marrow Transplant Clinical Trials Network

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2010.08.020 ◽

2011 ◽

Vol 17 (2) ◽

pp. 192-196 ◽

Cited By ~ 1

Author(s):

Edwin M. Horwitz ◽

Mary M. Horowitz ◽

Nancy L. DiFronzo ◽

Donald B. Kohn ◽

Helen E. Heslop

Keyword(s):

Clinical Trials ◽

Cell Therapy ◽

Phase Ii ◽

Marrow Transplant ◽

Blood And Marrow Transplant ◽

Therapy Trial

Download Full-text

Evaluation of Tumor Vaccine Generation in a Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant (AutoHCT)Followed By Lenalidomide Maintenance for Multiple Myeloma (MM) with or without Vaccination with Dendritic Cell/ Myeloma Fusions (DC/MM fusion vaccine): Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 1401

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2019.12.230 ◽

2020 ◽

Vol 26 (3) ◽

pp. S62-S63

Author(s):

David E. Avigan ◽

Nina Shah ◽

Brent Logan ◽

Jiaxi Zhu ◽

Lina Bisharat ◽

...

Keyword(s):

Multiple Myeloma ◽

Clinical Trials ◽

Dendritic Cell ◽

Phase Ii ◽

Tumor Vaccine ◽

Multicenter Trial ◽

Marrow Transplant ◽

Cell Transplant ◽

Hematopoietic Cell Transplant ◽

Blood And Marrow Transplant

Download Full-text

Phase II Trial of Non-Myeloablative Conditioning and Partially HLA-Mismatched (HLA-Haploidentical) Bone Marrow Transplantation (BMT) for Patients With Hematologic Malignancies: Results of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Protocol 0603

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2010.12.007 ◽

2011 ◽

Vol 17 (2) ◽

pp. S151 ◽

Cited By ~ 2

Author(s):

E.J. Fuchs ◽

J. Wu ◽

S. Carter ◽

C.G. Brunstein ◽

L.J. Costa ◽

...

Keyword(s):

Bone Marrow ◽

Clinical Trials ◽

Bone Marrow Transplantation ◽

Phase Ii ◽

Marrow Transplantation ◽

Phase Ii Trial ◽

Hematologic Malignancies ◽

Marrow Transplant ◽

Myeloablative Conditioning ◽

Blood And Marrow Transplant

Download Full-text

Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703)

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2017.12.798 ◽

2018 ◽

Vol 24 (4) ◽

pp. 700-707 ◽

Cited By ~ 7

Author(s):

Eileen P. Smith ◽

Hongli Li ◽

Jonathan W. Friedberg ◽

Louis S. Constine ◽

Lisa M. Rimsza ◽

...

Keyword(s):

Clinical Trials ◽

Hodgkin Lymphoma ◽

Cell Transplantation ◽

Phase Ii ◽

Hematopoietic Cell Transplantation ◽

Phase Ii Trial ◽

Marrow Transplant ◽

Hematopoietic Cell ◽

Blood And Marrow Transplant ◽

Autologous Hematopoietic Cell Transplantation

Download Full-text

Prednisone (PDN)/Sirolimus (SRL) Compared to PDN/SRL/Calcineurin Inhibitor (CNI) as Treatment for Chronic Graft-Versus-Host-Disease (cGVHD): A Randomized Phase II Study from the Blood and Marrow Transplant Clinical Trials Network

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2015.11.336 ◽

2016 ◽

Vol 22 (3) ◽

pp. S50-S52 ◽

Cited By ~ 3

Author(s):

Paul A. Carpenter ◽

Brent R. Logan ◽

Stephanie J. Lee ◽

Daniel J. Weisdorf ◽

Laura Johnston ◽

...

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Graft Versus Host Disease ◽

Calcineurin Inhibitor ◽

Phase Ii Study ◽

Marrow Transplant ◽

Host Disease ◽

Graft Versus Host ◽

Blood And Marrow Transplant ◽

Randomized Phase Ii

Download Full-text

Follistatin and Endoglin: Potential Biomarkers of Endothelial Damage and Non-Relapse Mortality after Myeloablative Allogeneic Hematopoietic Cell Transplantation in Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0402

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2017.01.030 ◽

2017 ◽

Vol 23 (3) ◽

pp. S73-S74

Author(s):

Laura F. Newell ◽

Todd E. Defor ◽

Corey S. Cutler ◽

Michael R. Verneris ◽

Bruce R. Blazar ◽

...

Keyword(s):

Clinical Trials ◽

Cell Transplantation ◽

Hematopoietic Cell Transplantation ◽

Marrow Transplant ◽

Endothelial Damage ◽

Hematopoietic Cell ◽

Allogeneic Hematopoietic Cell Transplantation ◽

Blood And Marrow Transplant ◽

Potential Biomarkers

Download Full-text

Translation of Clinical Research into Practice: An Impact Assessment of the Results from the Blood and Marrow Transplant Clinical Trials Network Protocol 0201 on Unrelated Graft Source Utilization

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2018.06.028 ◽

2018 ◽

Vol 24 (11) ◽

pp. 2204-2210 ◽

Cited By ~ 7

Author(s):

Nandita Khera ◽

Lih-Wen Mau ◽

Ellen M. Denzen ◽

Christa Meyer ◽

Kate Houg ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Impact Assessment ◽

Marrow Transplant ◽

Network Protocol ◽

Blood And Marrow Transplant

Download Full-text

Unrelated Donor Cord Blood Transplantation for Children with Severe Sickle Cell Disease: Results of a Phase II Study from the Blood and Marrow Transplant Clinical Trials Network

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2011.12.318 ◽

2012 ◽

Vol 18 (2) ◽

pp. S326

Author(s):

N.R. Kamani ◽

M. Walters ◽

S. Carter ◽

J.A. Brochstein ◽

M. Eapen ◽

...

Keyword(s):

Clinical Trials ◽

Sickle Cell Disease ◽

Cord Blood ◽

Phase Ii Study ◽

Cord Blood Transplantation ◽

Marrow Transplant ◽

Unrelated Donor ◽

Cell Disease ◽

Blood Transplantation ◽

Blood And Marrow Transplant

Download Full-text

A New Standard in Graft-versus-Host Disease Prophylaxis? An Introduction to Blood and Marrow Transplant Clinical Trials Network 1703

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2020.08.029 ◽

2020 ◽

Vol 26 (12) ◽

pp. e305-e308

Author(s):

Zachariah DeFilipp ◽

Linda J. Burns ◽

Samantha M. Jaglowski ◽

Aaron L. Leppin ◽

Steven Pavletic ◽

...

Keyword(s):

Clinical Trials ◽

Graft Versus Host Disease ◽

Marrow Transplant ◽

Host Disease ◽

Graft Versus Host ◽

Blood And Marrow Transplant

Download Full-text

Reduced-Intensity Conditioning with Fludarabine, Cyclophosphamide, and High-Dose Rituximab for Allogeneic Hematopoietic Cell Transplantation for Follicular Lymphoma: A Phase Two Multicenter Trial from the Blood and Marrow Transplant Clinical Trials Network

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2016.04.014 ◽

2016 ◽

Vol 22 (8) ◽

pp. 1440-1448 ◽

Cited By ~ 26

Author(s):

Ginna G. Laport ◽

Juan Wu ◽

Brent Logan ◽

Veronika Bachanova ◽

Chitra Hosing ◽

...

Keyword(s):

Clinical Trials ◽

Follicular Lymphoma ◽

Cell Transplantation ◽

Hematopoietic Cell Transplantation ◽

Multicenter Trial ◽

Marrow Transplant ◽

High Dose ◽

Reduced Intensity Conditioning ◽

Blood And Marrow Transplant ◽

Reduced Intensity

Download Full-text

When You Don't Need a Form 3674; FDA Is Asked for Guidance on Design of Pneumonia Trials; IRB Blocked from Granting Expedited Approvals; PhRMA Objects to Characterization of All Industry-Sponsored Clinical Trials as Biased; Protections for Subjects in Overseas Trials; Questionable Cell Therapy Trial Under Investigation in Austria; FDA to Increase Control of Clinical Trials; FDA, EMEA to Accept Biomarker Data on Renal Damage

Biotechnology Law Report ◽

10.1089/blr.2008.9934 ◽

2008 ◽

Vol 27 (4) ◽

pp. 320-322

Keyword(s):

Clinical Trials ◽

Cell Therapy ◽

Renal Damage ◽

Therapy Trial ◽

Biomarker Data

Download Full-text