肿瘤细胞治疗研究
英文原题：Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
这是一项 II 期注册临床试验，评估异体造血干细胞治疗急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 101 例。试验地点：中国 · 苏州（共 1 个中心，其中中国 1 个）。登记号：NCT07564453。
不限性别 · ≥ 15 Years 且 ≤ 65 Years
纳入标准： 1. 年龄≥15岁且≤65岁。 2. 根据WHO诊断标准新诊断为费城染色体阴性B细胞前体急性淋巴细胞白血病（B-ALL），且CD19表达≥20%。 3. 初治患者，既往未接受诱导治疗（羟基脲及≤5天的糖皮质激素治疗除外）。 4. ECOG体能状态评分0～3分。 5. 肝功能：总胆红素≤正常值上限（ULN）的3倍；丙氨酸氨基转移酶（ALT）≤ULN的3倍；天冬氨酸氨基转移酶（AST）≤ULN的3倍（白血病浸润所致情况除外）。 6. 肾功能：肌酐清除率（CrCl）≥30 mL/min。 7. 能够理解并自愿参加研究，且提供书面知情同意书。 排除标准： 1. 费城染色体阳性（Ph+、BCR-ABL1阳性）急性淋巴细胞白血病（ALL）。 2. T细胞急性淋巴细胞白血病。 3. 成熟B细胞白血病／淋巴瘤、B细胞淋巴母细胞淋巴瘤或髓外侵犯。 4. 急性混合表型白血病（MPAL）。 5. 中枢神经系统（CNS）白血病。 6. HIV感染。 7. HBV-DNA或HCV-RNA阳性。 8. 纽约心脏病协会（NYHA）心功能分级≥Ⅱ级，或研究者认为不适合入组的其他情况。 9. 妊娠期或哺乳期患者。 10. 拒绝参加研究的患者。
Inclusion Criteria: 1. Age ≥15 years and ≤65 years. 2. Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20% 3. De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days) 4. ECOG performance status score 0-3. 5. Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded). 6. Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min 7. Able to understand and voluntarily participate in the study, and provide written informed consent Exclusion Criteria: 1. Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL 2. T-cell acute lymphoblastic leukemia 3. Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion 4. Acute mixed phenotype acute leukemia (MPAL) 5. Central nervous system (CNS) leukemia 6. HIV infection 7. Positive HBV-DNA or HCV-RNA 8. New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator 9. Pregnant or lactating patients 10. Patients who refuse to enroll in the study
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 relapse-free survival (RFS) · Defined as the time from enrollment to relapse, death from any cause, or last follow-up, whichever occurs first. · From enrollment through 2 years post-last patient enrolled
次要终点：2-year overall survival (OS)；Composite Complete Remission (CR/CRi) Rate after Induction Therapy；Minimal Residual Disease (MRD) Negativity Rate
患者在诱导阶段接受减量化疗联合贝林妥欧单抗，随后在巩固阶段交替接受Hyper-CVAD（A/B）化疗、贝林妥欧单抗及序贯CD19靶向CAR-T治疗。部分患者（如KMT2A重排、TP53突变、MRD持续阳性或MRD复发者）接受异基因造血干细胞移植。
这是一项前瞻性单臂Ⅱ期临床试验，旨在评估以全疗程治疗方案（贝林妥欧单抗联合化疗）改善新诊断费城染色体阴性（Ph阴性）B细胞前体急性淋巴细胞白血病（B-ALL）患者生存结局的效果。研究采用“减量化疗+全疗程免疫治疗”策略：诱导阶段采用减量化疗联合贝林妥欧单抗，以提高缓解率和耐受性；巩固阶段交替使用Hyper-CVAD（A/B）方案、贝林妥欧单抗及序贯CD19靶向CAR-T治疗，以进一步清除微小残留病（MRD）；部分患者（如KMT2A重排、TP53突变、MRD持续阳性或MRD复发者）接受异基因造血干细胞移植；不进行维持治疗。 主要终点为2年无复发生存期（RFS）。次要终点包括2年总生存期（OS）、完全缓解（CRc）率及达到CRc的时间、MRD阴性率及达到MRD阴性的时间。 计划招募101名15～65岁患者，以与历史对照相比验证生存结局是否改善。
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy. The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity. The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .
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