Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
The Emmes Corporation, Rockville, MD, USA.
Biol Blood Marrow Transplant. 2019 Nov;25(11):2160-2166. doi: 10.1016/j.bbmt.2019.06.033. Epub 2019 Jul 4.
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).
我们着手在一项 II 期前瞻性多中心试验中评估 17 名 HIV 感染者接受同种异体造血细胞移植的可行性和安全性。主要终点为 100 天无复发生存率（NRM）。患者有 8/8 HLA 匹配的相关供体或至少 7/8 HLA 匹配的无关供体。移植适应证为急性白血病、骨髓增生异常综合征和淋巴瘤。预处理方案为清髓性或强度降低。100 天无 NRM。II 至 IV 级急性移植物抗宿主病（GVHD）的累积发生率为 41%。1 年总生存率为 59%；死亡原因分别为疾病复发/进展（n=5）、急性 GVHD（n=1）、成人呼吸窘迫综合征（n=1）和肝功能衰竭（n=1）。在完全嵌合体的患者中，血液中的细胞相关 HIV DNA 和可诱导的感染性病毒无法检测到。血液和骨髓移植临床试验网络 0903/艾滋病恶性肿瘤联盟 080 在 www.clinicaltrials.gov 上注册（编号 NCT01410344）。
