Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals (BMT CTN #0903)

The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT
for patients with chemotherapy-sensitive hematological malignancies and coincident
HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an
indicator of the safety of transplant in this patient population. Correlative assays will
focus upon the incidence of infectious complications in this patient population, the
evolution of HIV infection and immunological reconstitution. Where feasible (and when this
can be accomplished without compromise of either the donor quality or the timeliness of
transplantation), an attempt will be made to identify donors who are homozygotes for the
delta32 mutation for CCR5.

本试验的研究依据为验证异基因造血干细胞移植（allogeneic HCT）针对化疗敏感型血液系统恶性肿瘤合并HIV感染患者的可行性与安全性。具体而言，本试验将以100天非复发死亡率（non-relapse mortality）作为该患者群体移植安全性的核心评价指标。关联分析实验将聚焦于该患者群体的感染并发症发生率、HIV感染病程演变以及免疫重建（immunological reconstitution）情况。在可行且不损害供体细胞质量、不延误移植时机的前提下，本试验将尝试筛选携带CCR5基因Δ32纯合突变的供体。