肿瘤细胞治疗研究
英文原题：Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
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这是一项 II 期注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 34 例。试验地点：韩国 · 釜山、大邱（共 2 个中心）。登记号：NCT02859402。
不限性别 · ≥ 19 Years 且 ≤ 65 Years · 接受健康志愿者
纳入标准： 1. 年龄19–65岁。 2. 组织学确诊T细胞或NK细胞淋巴瘤，包括间变性大细胞淋巴瘤、血管免疫母细胞性T细胞淋巴瘤、非特指型外周T细胞淋巴瘤及NK/T细胞淋巴瘤。 3. 既往至少一种化疗（包括一线自体造血干细胞移植）后复发或难治。 4. 既往化疗后复发/难治时、挽救化疗前，通过常规CT或PET-CT至少存在一个可测量病灶。 5. 短疗程挽救化疗后达到完全或部分缓解。 6. 有HLA全相合（高分辨率DNA分型的HLA-A、B、C、DR位点8/8相合）或单个位点不相合（7/8）的同胞、无关骨髓/外周血供者，或脐带血干细胞供者。 7. ECOG体能状态≤2。 8. 移植前Charlson合并症指数（CCI）≤3。 9. 肾功能充分：血清肌酐<2.0 mg/dL。 10. 肝功能充分：AST/ALT<ULN的3倍；若淋巴瘤累及肝脏，可<ULN的5倍。总胆红素<ULN的2倍；若NK/T细胞淋巴瘤累及肝脏，可<ULN的5倍。 11. MUGA或二维超声心动图测得的射血分数≥50%，且无有临床意义的异常。 12. 无有临床意义的感染。 13. 无有临床意义的出血症状或体征。 14. 患者决定参加本研究并已签署书面知情同意书。 排除标准： 1. 成人T细胞白血病/淋巴瘤、淋巴母细胞性淋巴瘤、原发性皮肤CD30阳性T细胞疾病、蕈样肉芽肿或Sezary综合征。 2. 既往接受过异基因造血干细胞移植。 3. 原发累及中枢神经系统（CNS）的T细胞淋巴瘤；仅接受过针对CNS疾病的预防性鞘内或静脉化疗者可入组。 4. 已知HIV血清阳性或丙肝病毒（HCV）阳性。乙肝病毒（HBV）感染者可入组，但建议在整个治疗期间对乙肝携带者进行抗病毒预防，以避免HBV再激活。 5. 过去5年内患有其他恶性肿瘤；已根治的非黑色素瘤皮肤癌或宫颈原位癌除外。 6. 超声心动图测得射血分数<50%。 7. 肺功能检查FEV1<60%或DLCO<60%。 8. ECOG体能状态3或4。 9. 有严重合并症或疾病，包括规范治疗后仍严重或不稳定的心脏病、近3个月内心肌梗死、严重神经或精神疾病（包括痴呆或癫痫）、活动性未控制感染（包括乙肝和丙肝），或主治医生判断的其他严重疾病。 10. 妊娠或哺乳期女性；有生育能力且未采取充分避孕措施的女性。
Inclusion Criteria:
1. Age 19 - 65
2. Histologically confirmed T or NK cell lymphomas :
* anaplastic large cell lymphoma
* angioimmunoblastic T-cell lymphoma,
* peripheral T-cell lymphoma, NOS
* NK/T-cell lymphoma
3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
4. At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy
5. Complete or Partial response after short cycles of salvage chemotherapy
6. Patients who have HLA full-match (8/8 in HLA-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors
7. ECOG performance status ≤ 2
8. Charlson Comorbidity Index (CCI) before HSCT ≤ 3
9. Adequate renal function : serum creatinine level \< 2.0 mg/dL
10. Adequate liver function :
* Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of lymphoma involvement of the liver)
* Total bilirubin \< 2 X upper normal value (or \< 5 x ULN in the presence of NK/T involvement of the liver)
11. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality
12. No clinically significant infection
13. No clinically significant bleeding symptoms or sign
14. Patients who decided to participate in this study and signed for a written consent
Exclusion Criteria:
1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD
2. Patients who have previously performed Allo-HSCT
3. T cell lymphoma with primary central nervous system (CNS) Involvement.
\*\* However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
4. Patients with a known history of HIV seropositivity or HCV (+).
\*\* Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or prevent HBV reactivation during whole treatment period.
5. Any other malignancies within the past 5 years
\*\* Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
6. Ejection fraction \< 50% by a echocardiography
7. FEV1 \<60% or DLCO \<60% by a pulmonary function test
8. ECOG performance status 3 or 4
9. Combined serious medical problem or disease
* Serious or unstable heart disease although proper treatment
* Myocardial infarction in recent 3 months
* Underlying serious neurologic or psychiatric disease including dementia or seizure
* Active uncontrolled infection including hepatitis B and C
* Serious other medical problems observed by the doctors in charge of the patient
10. Pregnant or lactating women, women of childbearing potential not employing adequate contraception以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：2-year progression-free survival · 2 year progression-free survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided. · 2 years
次要终点：Response rate；Time to neutrophil engraftment；Time to platelet engraftment；2-year overall survival；100-days treatment-related mortality；Rate of regimen-related toxicities；Rate of hepatic venoocclusive disease (HVOD)；Acute graft-versus-host disease (GVHD) grades I-IV
预处理化疗：氟达拉滨和白消安，随后进行异基因造血干细胞移植。
复发/难治性T细胞淋巴瘤预后较差，异基因干细胞移植已显示出治疗作用。本临床试验研究氟达拉滨联合3天白消安作为预处理方案，随后进行异基因干细胞移植，评估其治疗既往化疗（包括自体移植）后复发或难治的T细胞及NK/T细胞淋巴瘤患者的安全性和疗效。
Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.
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