Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial.,Biology of Blood and Marrow Transplantation

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Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial.
Biology of Blood and Marrow Transplantation ( IF 5.609 ) Pub Date : 2019-07-04 , DOI: 10.1016/j.bbmt.2019.06.033
Richard F Ambinder ₁ , Juan Wu ₂ , Brent Logan ₃ , Christine M Durand ₁ , Ryan Shields ₄ , Uday R Popat ₅ , Richard F Little ₆ , Deborah K McMahon ₄ , Joshua Cyktor ₄ , John W Mellors ₄ , Ernesto Ayala ₇ , Lawrence D Kaplan ₈ , Ariela Noy ₉ , Richard J Jones ₁ , Alan Howard ₁₀ , Stephen J Forman ₁₁ , David Porter ₁₂ , Carlos Arce-Lara ₃ , Paul Shaughnessy ₁₃ , Lisa Sproat ₁₄ , Shahrukh K Hashmi ₁₅ , Adam M Mendizabal ₁₆ , Mary M Horowitz ₁₇ , Willis H Navarro ₁₈ , Joseph C Alvarnas ₁₁

Affiliation

Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
The Emmes Corporation, Rockville, MD, USA.
Department of Biostatistics, Medical College Wisconsin, Milwaukee, WI, USA.
Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Cancer Therapeutic Evaluation Program, National Cancer Institute, Bethesda, MD, USA.
Department of Medicine, University of South Florida, Tampa, FL, USA.
Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
Hematology Division, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
National Marrow Donor Program, Minneapolis, MN, USA.
Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA.
University of Pennsylvania Cancer Center, Philadelphia, PA, USA.
Texas Transplant Institute, San Antonio, TX, USA.
Mayo Clinic - Phoenix, Phoenix, AZ, USA.
Division of Hematology, Mayo Clinic - Rochester, Rochester, MN, USA.
Department of Epidemiology and Biostatistics, The George Washington University, Washington, DC, USA.
Division of Hematology/Oncology, Froedtert Memorial Lutheran Hospital and Medical College of Wisconsin Clinical Cancer Center, Milwaukee, WI, USA.
Atara Biotherapeutics, San Francisco, CA, USA.

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).

中文翻译：

HIV血液系统恶性肿瘤患者的同种异体造血细胞移植：BMT CTN-0903 / AMC-080试验。

我们着手进行一项II期前瞻性多中心试验，以评估17名HIV感染者进行同种异体造血细胞移植的可行性和安全性。主要终点为100天非复发死亡率（NRM）。患者具有8/8 HLA匹配的相关供体或至少7/8 HLA匹配的无关的供体。移植的适应症是急性白血病，骨髓增生异常和淋巴瘤。调理是清髓或降低强度。100天没有NRM。II至IV级急性移植物抗宿主病（GVHD）的累积发生率为41％。一年后，总生存率为59％；死因是复发/进行性疾病（n = 5），急性GVHD（n = 1），成人呼吸窘迫综合征（n = 1）和肝衰竭（n = 1）。在完全嵌合的患者中，无法检测到血液中与细胞相关的HIV DNA和可诱导的传染性病毒。血液和骨髓移植临床试验网络0903 / AIDS恶性联盟080已在www.clinicaltrials.gov（编号NCT01410344）注册。

更新日期：2019-07-04

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