Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial

Richard F Ambinder; Juan Wu; Brent Logan; Christine M Durand; Ryan Shields; Uday R Popat; Richard F Little; Deborah K McMahon; Joshua Cyktor; John W Mellors; Ernesto Ayala; Lawrence D Kaplan; Ariela Noy; Richard J Jones; Alan Howard; Stephen J Forman; David Porter; Carlos Arce-Lara; Paul Shaughnessy; Lisa Sproat; Shahrukh K Hashmi; Adam M Mendizabal; Mary M Horowitz; Willis H Navarro; Joseph C Alvarnas

doi:10.1016/j.bbmt.2019.06.033

Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial

Biol Blood Marrow Transplant. 2019 Nov;25(11):2160-2166. doi: 10.1016/j.bbmt.2019.06.033. Epub 2019 Jul 4.

Authors

Richard F Ambinder¹, Juan Wu², Brent Logan³, Christine M Durand⁴, Ryan Shields⁵, Uday R Popat⁶, Richard F Little⁷, Deborah K McMahon⁵, Joshua Cyktor⁵, John W Mellors⁵, Ernesto Ayala⁸, Lawrence D Kaplan⁹, Ariela Noy¹⁰, Richard J Jones⁴, Alan Howard¹¹, Stephen J Forman¹², David Porter¹³, Carlos Arce-Lara³, Paul Shaughnessy¹⁴, Lisa Sproat¹⁵, Shahrukh K Hashmi¹⁶, Adam M Mendizabal¹⁷, Mary M Horowitz¹⁸, Willis H Navarro¹⁹, Joseph C Alvarnas¹²

Affiliations

¹ Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: rambind1@jhmi.edu.
² The Emmes Corporation, Rockville, MD, USA.
³ Department of Biostatistics, Medical College Wisconsin, Milwaukee, WI, USA.
⁴ Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁵ Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
⁶ Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁷ Cancer Therapeutic Evaluation Program, National Cancer Institute, Bethesda, MD, USA.
⁸ Department of Medicine, University of South Florida, Tampa, FL, USA.
⁹ Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁰ Hematology Division, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
¹¹ National Marrow Donor Program, Minneapolis, MN, USA.
¹² Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA.
¹³ University of Pennsylvania Cancer Center, Philadelphia, PA, USA.
¹⁴ Texas Transplant Institute, San Antonio, TX, USA.
¹⁵ Mayo Clinic - Phoenix, Phoenix, AZ, USA.
¹⁶ Division of Hematology, Mayo Clinic - Rochester, Rochester, MN, USA.
¹⁷ Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC, USA.
¹⁸ Division of Hematology/Oncology, Froedtert Memorial Lutheran Hospital and Medical College of Wisconsin Clinical Cancer Center, Milwaukee, WI, USA.
¹⁹ Atara Biotherapeutics, San Francisco, CA, USA.

Abstract

We set out to assess feasibility and safety of allogeneic hematopoietic cell transplant in 17 persons with HIV in a phase II prospective multicenter trial. The primary endpoint was 100-day nonrelapse mortality (NRM). Patients had an 8/8 HLA-matched related or at least a 7/8 HLA-matched unrelated donor. Indications for transplant were acute leukemia, myelodysplasia, and lymphoma. Conditioning was myeloablative or reduced intensity. There was no NRM at 100 days. The cumulative incidence of grades II to IV acute graft-versus-host disease (GVHD) was 41%. At 1 year, overall survival was 59%; deaths were from relapsed/progressive disease (n = 5), acute GVHD (n = 1), adult respiratory distress syndrome (n = 1), and liver failure (n = 1). In patients who achieved complete chimerism, cell-associated HIV DNA and inducible infectious virus in the blood were not detectable. Blood and Marrow Transplant Clinical Trials Network 0903/AIDS Malignancy Consortium 080 was registered at www.clinicaltrials.gov (no. NCT01410344).

Keywords: Allogeneic hematopoietic transplantation; Bone marrow; HIV.

Publication types

Clinical Trial, Phase II
Multicenter Study
Research Support, N.I.H., Extramural

MeSH terms

Adult
Allografts
Female
Graft vs Host Disease / blood
Graft vs Host Disease / etiology
Graft vs Host Disease / mortality
Graft vs Host Disease / prevention & control
HIV Infections / blood
HIV Infections / mortality
HIV Infections / therapy*
HIV-1*
Hematologic Neoplasms / blood
Hematologic Neoplasms / mortality
Hematologic Neoplasms / therapy*
Hematopoietic Stem Cell Transplantation*
Humans
Male
Middle Aged
Prospective Studies
Respiratory Distress Syndrome / blood
Respiratory Distress Syndrome / etiology
Respiratory Distress Syndrome / mortality
Respiratory Distress Syndrome / prevention & control
Transplantation Conditioning*

Associated data

ClinicalTrials.gov/NCT01410344

Abstract

Publication types

MeSH terms

Associated data

Grants and funding