自体造血干细胞移植治疗恶性血液病、肺癌临床观察

用自体造血干细胞移植（ＡＨＳＣＴ）治疗３例急性非淋巴细胞性白血病（ＡＮＬＬ）、１例霍奇金病（ＨＤ）和１例晚期肺癌（ＡＬＣ）。其中４例接受自体外周血干细胞移植（ＡＰＢＳＣＴ），１例接受自体骨髓移植（ＡＢＭＴ）。ＡＮＬＬ、ＨＤ、ＡＬＣ分别用ＭＡＣ、ＳＥＡＭ、ＳＥＥＣ方案预处理。５例患者移植后均获造血重建。ＡＮＬＬ和ＨＤ已分别持续完全缓解４８９天、３７２天、３３５天、２３０天；１例ＡＬＣ患者在移植后完全缓解１１５天后出现颅内复发。初步结果提示ＡＨＳＣＴ能延长ＡＮＬＬ、ＨＤ和ＡＬＣ患者的无病存活期     

造血系统恶性肿瘤外周血干细胞分离冻存及其临床应用

报告应用Ｈａｅｍｏｎｅｔｉｃｓ Ｖ５０ ＰＬＵＳ血细胞分离机对４种造血系统恶性肿瘤病人进行外周血干细胞采集，冻存的结果，第１次完全缓解早期４例病 均能收集到足够的外周血干细胞量进行自体移植，１例病人静脉应用动员剂ＧＭ－ＣＳＦ能提高外周血干细胞的采集效率，初步观察到化疗药物的累积损害对外周血干细胞的采集有不利影响。     

自体造血干细胞移植治疗老年恶性血液病的疗效和安全性

目的 自体造血干细胞移植是血液系统肿瘤的有效治疗选择，但在老年患者中的应用仍有争议，本文旨在分析自体造血干细胞移植在老年患者中的疗效和安全性。方法 回顾性分析2016年1月—2022年12月在华东医院血液科接受自体造血干细胞移植的患者数据，根据患者年龄分为老年组(≥60岁，n=25)和中青年组(<60岁，n=174),比较2组的外周造血干细胞动员效果、造血重建效果、肿瘤复发率、不良反应发生率和长期预后。结果 与中青年组比较，老年组的造血干细胞动员效果和重建速率差异均无统计学意义(P>0.05),且不加重移植相关的不良反应。长期预后分析显示2组均未达到中位总生存期和中位无进展生存期，2组5年生存率和5年无进展生存率无差异，多因素分析表明年龄不是影响自体造血干细胞移植预后的独立危险因素。结论 自体造血干细胞移植对于体能良好的老年恶性血液病患者是安全有效的治疗选择。     

自体造血干细胞移植20例及远期随访

目的:探讨自体造血干细胞移植的方法与预后。方法:回顾性分析20例自体造血干细胞移植的病例资料并长期随访。结果:20例自体移植顺利实现造血重建,无移植相关死亡,远期死亡7例,均为复发所致。讨论:自体造血干细胞移植安全性好,无病生存期显著延长,死亡主要原因为肿瘤复发。     

硼替佐米联合地塞米松方案诱导后续不同方法巩固治疗多发性骨髓瘤长期疗效观察

目的比较以硼替佐米联合地塞米松(VD)方案诱导治疗达到完全缓解/接近完全缓解(CR/nCR)疗效的多发性骨髓瘤(MM)患者接受自体造血干细胞移植和VD方案作为不同巩固治疗的疗效和预后。方法回顾性分析2006年7月至2009年2月中山大学附属第一医院血液科23例经VD方案诱导达到CR/nCR疗效的MM患者的临床资料。16例(移植组)接受自体造血干细胞移植作为巩固,7例(非移植组)继续应用VD方案巩固2～4个疗程。两组患者巩固治疗后均接受50～200mg反应停维持治疗直至复发。结果移植组患者在巩固治疗后有7例患者(7/16,43.8%)疗效进一步增加,中位随访15个月时所有患者均存活,处于无疾病进展状态;非移植组在中位随访13个月时,2例患者疾病进展,再次诱导治疗无效死亡。VD方案不影响干细胞采集,所有患者的干细胞植入顺利,中位中性粒细胞恢复时间16d(10～30d),中位血小板恢复时间20d(9～100d)。VD方案的常见不良反应包括胃肠道(47.8%)、疲乏(26.1%)、血小板减少(26.1%)、周围神经炎(52.2%)和感染(26.1%),3～4级毒副反应发生率低。结论自体造血干细胞移植的地位仍不可替代,VD方案诱导化疗后以自体移植作为巩固,是治疗年轻MM患者的最佳选择。     

造血干细胞移植治疗白血病8例疗效观察

目的评价造血干细胞移植治疗白血病的疗效。方法2000年8月~2006年8月在我科住院的白血病患者8例,预处理后接受造血干细胞移植,自体外周血干细胞移植2例,自体骨髓移植1例,异体外周血干细胞移植3例,异体骨髓移植1例,非血缘脐带血干细胞移植1例。移植后进行对症治疗及相关并发症的预防。结果8例患者均获造血重建,2例死于移植相关合并症,2例死于急性白血病复发,4例无病生存24~66个月。结论造血干细胞移植治疗白血病是一种较好的方法,可以提高白血病患者的长期生存率。     

自体造血干细胞移植后DC-CIK细胞预防急性白血病复发的效果探讨

目的 探讨白血病自体造血干细胞移植后应用树突状细胞-细胞因子诱导的杀伤细胞(DC-CIK细胞)预防急性白血病复发的临床疗效.方法 4例白血病自体造血干细胞移植后静注及腹股沟注射DC-CIK 细胞3次,观察疾病的复发情况以及DC-CIK细胞输注后的不良反应.结果 3例治疗后持续完全缓解(CR),CR期分别为32、36、45个月;1例急性非淋巴细胞白血病(M4)复发后进行异基因半相合造血干细胞移植,无病生存24个月.结论 DC-CIK细胞治疗可能协助清除微小残留病、预防复发,可作为白血病自体造血干细胞移植后预防复发的有效方法.     

VRD方案序贯自体造血干细胞移植治疗新诊断多发性骨髓瘤患者的疗效和安全性研究

目的探讨70岁及以下初诊多发性骨髓瘤(MM)患者接受VRD方案(硼替佐米、来那度胺联合地塞米松)诱导治疗后自体造血干细胞采集率和行序贯自体造血干细胞移植术的疗效及安全性。方法回顾性病例系列研究。收集2018年8月1日至2020年6月30日在苏州大学附属第一医院和苏州弘慈血液病医院诊治的123例适合行VRD方案序贯自体造血干细胞移植的初诊MM患者的临床资料, 回顾性分析其临床特征、诱导治疗后效果、动员自体干细胞方案、自体造血干细胞采集率, 以及自体造血干细胞移植的副作用和疗效。结果 123例患者中男性67例, 中位年龄为56岁(范围31～70岁), IgG、IgA、IgD、轻链型分别占47.2%(58例)、23.6%(29例)、3.2%(4例)、26.0%(32例);肾功能不全(肌酐清除率<40 ml/min)占25.2%(31例);修订的国际分期体系(R-ISS分期)Ⅲ期者占18.2%(22/121)。123例患者经过诱导治疗后部分缓解及以上率为82.1%(101例), 非常好的部分缓解(VGPR)及以上率为75.6%(93例), 完全缓解+严格意义的完全缓解率为45.5%(56...     

自体造血干细胞移植治疗老年多发性骨髓瘤的单中心回顾性分析

目的分析65岁以上老年多发性骨髓瘤患者接受自体造血干细胞移植治疗疗效和安全性。方法回顾性分析了自2020年3月1日至2022年10月31日在苏州弘慈血液病医院诊断并接受自体干细胞移植的28例65岁以上多发性骨髓瘤患者的疗效和安全性。接受移植的老年患者在移植前均进行了重要脏器功能评估。结果 28例患者接受移植时中位年龄67(66～72)岁, 中位采集造血干细胞CD34+细胞数为2.985×106/kg(2.036～9.5×106/kg), 中位采集天数2(1～3)d;造血干细胞回输后中性粒细胞植入中位时间10(9～14)d, 血小板植入中位时间11(10～29)d。中位随访时间25个月, 中位无进展生存时间未达到, 1年无进展生存期(PFS)率89.3%, 2年PFS率76.3%(其中2例行挽救性自体造血干细胞移植患者PFS起点设定为移植前再诱导治疗), 中位总生存时间未达到, 1年总生存期(OS)率100.0%, 2年OS率90.5%。结论对于经过评估筛选的65岁以上的老年多发性骨髓瘤患者, 自体造血干细胞移植是安全有效的治疗方案。     

自体造血干细胞移植对急性髓系白血病的治疗进展

自20世纪80年代至今,自体造血干细胞移植已成为一种治疗急性髓系白血病(AML)的主要疗法。目前自体造血干细胞移植成为因难以找到人类白细胞抗原(HLA)配型相合者而不能行异基因造血干细胞移植的主要治疗手段。该文综述了自体造血干细胞移植在低危、中高危AML及难治性或复发性AML患者中的治疗进展,追踪了降低自体造血干细胞移植治疗AML复发率的策略。     

FLAG-IDA in the treatment of refractory/relapsed acute myeloid leukemia: single-center experience

We evaluated the efficacy and toxicity profiles of the combination of fludarabine, high-dose cytosine arabinoside (AraC), idarubicin, and granulocyte colony-stimulating factor (G-CSF) in refractory/relapsed acute myeloblastic leukemia (AML) patients. Between October 1998 and February 2002, 46 AML patients were treated with FLAG-IDA (fludarabine 30 mg/m(2), AraC 2 g/m(2) for 5 days, idarubicin 10 mg/m(2) for 3 days, and G-CSF 5 micro g/kg from day +6 until neutrophil recovery). Thirty patients were in relapse after conventional chemotherapy including cytarabine, etoposide, and daunorubicin or mitoxantrone according to the GIMEMA protocols. Four were in relapse after autologous peripheral stem cell transplantation and two after allogeneic bone marrow transplantation. Ten patients had refractory disease (after 10 days of standard doses of cytarabine, 3 days of mitoxantrone or daunorubicin, and 5 days of etoposide). Recovery of neutrophils and platelets required a median of 19 and 22 days from the start of therapy. Complete remission (CR) was obtained in 24 of 46 patients (52.1%) and 3 of 46 (6.6%) died during reinduction therapy: 2 due to cerebral hemorrhage and 1 due to fungemia ( Candida tropicalis). Fever >38.5 degrees C was observed in 40 of 46 patients (86.9%), 27 had fever of unknown origin (FUO) and 13 documented infections; 31 of 46 (67.3%) developed mucositis and 14 of 46 (30.4%) had grade 2 WHO transient liver toxicity. After achieving CR, 11 patients received allogeneic stem cell transplantation, 4 patients received autologous stem cell transplantation, 4 were judged unable to receive any further therapy, and 5 refused other therapy. Ten patients are at present in continuous CR after a median follow-up of 13 months (range: 4-24). In our experience, FLAG-IDA is a well-tolerated and effective regimen in relapsed/refractory AML. The toxicity is acceptable, enabling most patients to receive further treatment, including transplantation procedures.     

自体外周血干细胞移植治疗原发性系统性淀粉样变性

目的:评价大剂量马法兰联合自体外周血干细胞移植(AHSCT)治疗原发性系统性淀粉样变性(简称AL淀粉样变性)的初步疗效及安全性。方法:从2010年7月至2011年1月共有13例AL淀粉样变性患者在南京军区南京总医院全军肾脏病研究所接受AHSCT治疗,所有患者均经肾活检明确诊断。采用粒细胞集落刺激因子(G-CSF)动员采集干细胞,采集成功后2～6周内接受干细胞移植治疗,预处理方案为大剂量马法兰,根据患者危险分层采用100mg/m2、140mg/m2和200mg/m2三种剂量。受累器官及疗效判断采用第10届国际淀粉样变性研讨会制订的标准。结果:13例患者均以肾脏为首发表现就诊,经肾活检明确诊断,肾组织λ轻链沉积11例,κ轻链沉积2例。受累器官1～3个(仅评价肾脏、心脏、肝脏及神经系统等重要器官),患者均有肾脏受累,10例(76.9%)心脏受累,2例(15.4%)肝脏受累,1例(7.7%)外周神经受累。4例患者诊断后直接行AHSCT治疗,其余患者移植前均接受过不同方案的化疗。所有患者均成功采集干细胞,采集过程中的主要并发症为低钙血症、低钾血症及血小板减低。采集CD34+细胞计数2.0～8.36×106/kg[平均(4.02±2.01)×106/kg]。所有患者造血均重建,粒缺期3～7d(中位时间4d),中性粒细胞植入时间9～13d(中位时间9d),血小板植入时间10～21d(中位时间13d)。移植过程主要并发症为恶心、呕吐(84.6%),黏膜炎(76.9%),粒缺期发热(53.8%),心律失常(53.8%),急性肾损伤(46.2%)及腹泻(30.8%)等,其他少见并发症有急性肝损伤、肝破裂出血、胸腔积液和败血症等。移植后100d内1例患者因肝破裂出血死亡,治疗相关死亡率为7.7%。移植后随访4～10月,有8例(61.5%)患者取得血液学反应,其中完全缓解5例(38.5%),部分缓解3例(23%)。7例(53.8%)患者取得器官反应,其中3例为肾脏及心脏均起反应,4例为肾脏反应,其余患者器官无反应。结论:对严格选择的AL淀粉样变性患者,AHSCT是一种安全有效的治疗手段,致死性并发症少且有较高的血液学及器官反应率,然而其远期疗效还有待进一步观察。     

免疫清除性化疗结合自体外周血造血干细胞移植治疗重症系统性红斑狼疮

目的 观察免疫清除性化疗结合自体外周血造血干细胞移植（移植）治疗重症系统性红斑狼疮（SLE）的疗效及安全性。方法 重症SLE4例，分别合并狼疮性肾炎，狼疮脑，狼疮心或股骨头坏死，干细胞的动员采用环磷酰胺加重组人粒细胞集落因子（G－CSF）；预处理为回输前3天每天应用环磷酰胺50mg/kg 回输后3天每天应用抗胸腺细胞球蛋白（ATG）5mg/kg。观察移植前后临床症状，体征，狼疮相关抗体等指标的改变，并动态观察移植后免疫功能的重建。结果 移植后患者的临床症状完全缓解，狼疮相关抗体全部转阴，移植后患者的免疫功能均明显降低，约半年后恢复正常，但不伴有临床症状的复发。结论 免疫清除性化疗结合自体外周血造血干细胞移对难治性SLE有明显的疗效，尤其适用对各种药物治疗无效者，治疗是安全的，远期疗效还需长期随访。     

Rituximab (anti-CD20 monoclonal antibody) therapy for progressive intermediate-grade non-Hodgkin's lymphoma after high-dose therapy and autologous peripheral stem cell transplantation.

We evaluated the response and toxicity of rituximab in the setting of progressive intermediate grade non-Hodgkin's lymphoma (NHL) after autologous peripheral stem cell transplantation (PSCT). Seven patients with a median age of 59 years (45-62), ECOG performance status 0-1, and CD20-positive diffuse large cell lymphoma with progression after PSCT were treated. All patients initially received 4-weekly infusions of rituximab (375 mg/m2). The maximum response was three CR and four PR. Median progression-free survival was 197 days (range 60-282). With a median follow-up of 204 (115-299) days, the patients' disease status is classified as two CR, one PR, and four PD. Four of five patients with ECOG performance status of 1 prior to treatment showed improvement to status 0 after treatment with rituximab. While follow-up is short, these results suggest that rituximab has significant activity in intermediate-grade non-Hodgkin's lymphoma that has relapsed after PSCT.     

Phase II study of a high-dose ifosfamide-based chemotherapy regimen with growth factor rescue in recurrent aggressive NHL. High response rates and limited toxicity, but limited impact on long-term survival

The purpose of the study was to evaluate in patients with recurrent intermediate-grade NHL, the tolerance to and efficacy of an intensive salvage regimen consisting of high doses of ifosfamide, etoposide and mitoxantrone with G-CSF support, followed by autologous stem cell transplantation and to identify prognostic factors for survival in patients with recurrent aggressive lymphoma. Patients with recurrent intermediate-grade NHL under the age of 60 years were eligible. Induction consisted of ifosfamide 10 g/m(2) and etoposide 900 mg/m(2) with G-CSF 5 microg/kg twice a day. Upon recovery, patients underwent stem cell apheresis. Patients achieving complete remission (CR) underwent autologous stem cell transplantation using BEAM conditioning. Those with partial remission (PR) received treatment with ifosfamide 10 g/m(2), mitoxantrone 20 mg/m(2) and G-CSF 5 microg/kg. Those with CR received BEAM, those with PR received cyclophosphamide 4.5 g/m(2), etoposide 1200 mg/m(2) and cisplatin 135 mg/m(2) with stem cell rescue followed by BEAM. Antibiotic prophylaxis was given with all treatment cycles. The results were compared with those obtained in a prior study that used MINE-ESHAP salvage. Forty-four patients with recurrent intermediate-grade NHL were enrolled between March 1994 and September 1996. Median age was 50 years (24-61). Eleven patients had transformed lymphoma and seven had a T cell phenotype. Response rate to the high-dose ifosfamide regimen was 77% +/- 12% after two cycles and the complete response rate was 41% +/- 14%. Myelosuppression was profound but short. Median nadir ANC was 0 and the median duration of ANC <0.5 x 10(9)/l was 6 days (range 3-12). No severe infections occurred; 55% of the patients required blood transfusion and 42% required platelet transfusions. Myelosuppression and transfusion requirements were similar after the first and second cycles. Thirty-five of the 44 patients proceeded to autologous stem cell transplantation and one transplant-related death occurred. With a median follow-up of 52 months, progression-free survival at 2 years is 38% +/- 14% and survival is 52% +/- 15%. Data from these 44 patients were pooled with data on 53 patients who had received salvage treatment with MINE-ESHAP, for a multivariate analysis of prognostic factors. In multivariate analysis, serum LDH was strongly associated with survival. The use of a more intensive salvage regimen, did not result in a significant increase in long-term outcome, despite a high response rate. In conclusion, duration of treatment, response rates, treatment-related mortality and survival compare favorably with previous salvage regimens, but recurrence remains a major problem. Long-term survival in recurrent large cell lymphoma is influenced more by disease characteristics than by the type of salvage regimen used.     

Autologous Hematopoietic Stem Cell Transplantation for 3 Patients with Severe Juvenile Rheumatoid Arthritis

We performed autologous CD34+ stem cell transplantation in 3 patients with juvenile rheumatoid arthritis (JRA) refractory to conventional treatment. All patients had systemic type JRA. In case 1 (a 3-year-old boy), purified CD34+ cells from bone marrow were transplanted after a preconditioning regimen consisting of cyclophosphamide (200 mg/kg) and antithymocyte globulin (ATG) (40 mg/kg). However, the disease flared soon after transplantation. In case 2 (a 13-year-old girl) and case 3 (a 21-year-old woman), a preconditioning regimen consisting of etoposide (VP16) (2 g/m2), thiotepa (300 mg/m2), and ATG (40 mg/kg) was followed by transplantation of purified CD34+ stem cells harvested from peripheral blood mononuclear cells. The patients in cases 2 and 3 attained complete remission without any medication. Thus for patients with refractory JRA, autologous CD34+ cell transplantation appears to be a safe and feasible choice of treatment in terms of good quality of life. However, a greater number of patients and a longer observation period are needed before definitive conclusions can be drawn.     

Autologous blood stem cell (ABSCT) versus purged bone marrow transplantation (pABMT) in standard risk AML: influence of source and cell composition of the autograft on hemopoietic reconstitution and disease-free survival.

Complete and sustained hemopoietic function following myeloablative therapy can be successfully achieved by autologous transfusion of blood derived hemopoietic stem cells. It was the purpose of this study to compare autologous blood stem cell transplantation (ABSCT) in 20 patients with autologous transplantation of a mafosfamide purged marrow (pABMT) in 23 patients; all were transplanted in first complete remission (CR) of acute myelogenous leukemia (AML) using the same pretransplant regimen (14.4 Gy total body irradiation and 200 mg/kg cyclophosphamide). The autografts, mostly differing in source of hemopoietic stem cells, cell composition and CFU-GM number, were evaluated for their ability to reconstitute hemopoiesis and induce long-term disease-free survival (DFS). Prior to harvest, hemopoietic stem cells were mobilized by inducing transient myelosuppression (ara-C 100 mg/m2 every 12 h s.c. days 1-5 and daunorubicin 45 mg/m2, days 3 and 4) followed by an overshooting of peripheral stem cell concentration.(ABSTRACT TRUNCATED AT 250 WORDS)     

Fludarabine as a risk factor for poor stem cell harvest, treatment-related MDS and AML in follicular lymphoma patients after autologous hematopoietic cell transplantation

Fludarabine is an effective treatment for follicular lymphoma (FL), but exposure to it negatively impacts stem cell mobilization and may increase the risk of subsequent myelodysplastic syndrome and acute myelogenous leukemia (t-MDS/AML). We hypothesized that the risk that fludarabine imparts to stem cell mobilization and t-MDS/AML would be affected by dose or timing. All patients with FL treated at Cleveland Clinic from 1991 to 2007 with autologous hematopoietic cell transplantation were evaluated. Recursive partitioning analysis was used to explore associations of fludarabine and mitoxantrone dose and timing with poor stem cell harvest and t-MDS/AML. We identified 171 patients, of whom 52 previously received fludarabine. Patients exposed to fludarabine prior to auto-HCT were more likely to require >5 days of leukapheresis (P<0.001) and second stem cell mobilization (P<0.001), especially at a cumulative dose >150 mg/m(2). Univariable risk factors for t-MDS/AML included the number of chemotherapy regimens before auto-HCT, the need for >5 days of leukapheresis to collect CD34+ cells and fludarabine exposure in a dose-dependent manner, particularly when >500 mg/m(2). A cumulative dose of fludarabine >150 mg/m(2) increases the risk for poor stem cell harvests and any exposure increases the risk of t-MDS/AML, with the greatest risk being at doses >500 mg/m(2).     

Modulations of dose intensity of doxorubicin and cyclophosphamide in association with G-CSF and peripheral blood stem cells in adjuvant chemotherapy for breast cancer: comparative evaluation of completion and safety of three intensive regimens

The aim of this study was to evaluate and to compare in terms of toxicity the modulations of dose intensity of cyclophosphamide and doxorubicin in adjuvant chemotherapy for high-risk breast cancer. Four cycles of sequential high-dose chemotherapy with doxorubicin and cyclophosphamide (AC), supported with G-CSF and peripheral blood stem cells (PBSC) were administered to 81 women. Three successive cohorts were studied: doxorubicin (75 mg/m(2)) + cyclophosphamide (3000 mg/m(2)) every 21 days (group 1), doxorubicin (75 mg/m(2)) + cyclophosphamide (3000 mg/m(2)) every 15 days (group 2), and doxorubicin (75 mg/m(2)) + cyclophosphamide (6000 mg/m(2)) every 21 days (group 3). Seventy-five patients received four cycles of treatment with a total of 310 cycles administered. The received dose intensity of doxorubicin was higher in group 2 and that of cyclophosphamide was lower in group 1 than in the other two groups. Hematological and extra-hematological toxicities, as well as the number and duration of hospitalizations for toxicity, were significantly higher in group 3. We conclude that the group 3 regimen is associated with toxicities comparable to autologous transplantation. Increasing dose intensity of doxorubicin and cyclophosphamide is feasible in an outpatient setting and safe in groups 1 and 2 with the support of hematopoietic factor and PBSC.     

Immunotherapy with interleukin-2 and alpha-interferon after IL-2-activated hematopoietic stem cell transplantation for breast cancer

We previously demonstrated findings suggestive of autologous GVHD in patients receiving IL-2-activated peripheral blood stem cells (PBSC) with IL-2 after transplantation. A pilot study was designed to test tolerability, feasibility and frequency of autologous GVHD and engraftment using IL-2 and alpha-IFN post-transplantation. After cyclophosphamide (6 g/m2) and carboplatin (1800 mg/m2), patients with high-risk stage II or III breast cancer received chemotherapy and rhG-CSF mobilized autologous PBSC that had been cultured in IL-2 for 24 h. Subcutaneous administration of IL-2 began on day 0 at 6 x 10(5) IU/m2/day for 5 of 7 days each week and continued for 4 weeks. Once engraftment occurred, alpha-IFN was initiated at a dose of 1 x 10(6)/m2/day subcutaneously for 30 days. Thirty-four consecutive patients with stage II (n=20), IIIA (n=6) and IIIB (n=8) disease were treated. All patients were without evidence of disease at the time of transplantation. The average time required for the ANC to reach 500/mm3 was 10 days (range: 8-11 days) and for platelets to reach 20000/mm3 was 10.7 days (range: 6-21 days). Forty-seven percent of patients (n=16) completed the full course of immunotherapy; the remaining patients received attenuated doses due to patient's request (n=6), development of temperature >38 degrees C (n=3), development of neutropenia (n=3), serious infection (n=1) and miscellaneous reasons (n=5). Four patients experienced transient moderate toxicities (level 3) including elevated liver function tests, nausea, rash and capillary leak syndrome. Pathological findings suggestive of skin GVHD developed in 43% of patients (12/28 patients) when skin biopsies were evaluated in a blinded fashion. At 13 months post-transplant (median; range: 5-24 months), 28 patients (82%) remain disease-free. These results demonstrate the feasibility and toxicity of this regimen along with pathological findings compatible with autologous GVHD of the skin.