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正在招募II 期 / III 期编号 NCT07059156

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

报名条件（概要）

  • 年龄：18 Years – 60 Years
  • 性别：不限
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

Induction Therapy Regimen药物

VICP+VEN regimen: * Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22. * Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22. * Cyclophosphamide (CTX): 500 mg/m², days 7, 21. * Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28 * Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day

Pre-Treatment Regimen药物

Indications for pre-treatment: * WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy. * Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities). Pre-treatment protocol: * Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg/kg/day (PO/IV) for 3-5 days. * Optional addition of CTX: 200 mg/m²/day IV for 3-5 days.

Post-CR Treatment其他

Principles: 1. MRD-positive or rising: Administer blinatumomab (CD19/CD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. MRD-negative/unknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical/genetic features.

Post-CR Consolidation Regimens药物

① Hyper-CVAD-B (Methotrexate/Cytarabine-based): * Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH \>7.0) and leucovorin rescue. * Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses). * Dexamethasone: 40 mg/day (PO/IV, Days 1-4). * Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen: * CTX: 750 mg/m² IV (split over 2 days). * Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks). * 6-MP: 50-75 mg/m²/day fasting (7-14 days PO).

Transplant-Eligible Subsequent Therapy其他

* Allo-HSCT for eligible patients after induction. * Conditioning regimen: TBI-VP16-CY. * Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo).(Consider age/donor health status).

Allo-HSCT Protocol其他

1.6.1 Conditioning Regimen (TBI-VP16-Cy/ATG): * TBI: 5 Gy (Days -7 to -6). * VP16: 10 mg/kg/day (Days -5 to -4). * CTX: 30 mg/kg/day (Days -3 to -2). * ATG: 7.5 mg/kg/day (Days -5 to -2). 1.6.2 GVHD Prophylaxis: * Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4). * Standard regimen: Cyclosporine (CsA): IV: 2 mg/kg/day (start Day -9; target level 150-250 μg/L). PO: 3-5 mg/kg/day BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate.

Non-Transplant Maintenance Therapy Options其他

① Hyper-CVAD-B (Methotrexate/Cytarabine-based): * Methotrexate (MTX): 1 g/m² IV over 24h (Day 1) with urine alkalinization (pH \>7.0) and leucovorin rescue. * Cytarabine (Ara-C): 1 g/m² IV q12h (Days 2-3; total 4 doses). * Dexamethasone: 40 mg/day (PO/IV, Days 1-4). * Cycle interval: 21-28 days (alternating with other regimens). ② CAM Regimen: * CTX: 750 mg/m² IV (split over 2 days). * Ara-C: 75 mg/m²/dose (8 days; 1-2 doses/day IV; if once daily, administer 5 days/week × 2 weeks). * 6-MP: 50-75 mg/m²/day fasting (7-14 days PO). * Maintenance (6-MP/MTX alternating with V-Dex): 6-MP: 75 mg/m²/day at bedtime (Days 1-21); MTX: 20 mg/m² IM weekly × 3 weeks.\*Adjust doses to maintain WBC \~3×10⁹/L, ANC 1.0-1.5×10⁹/L.\*

研发企业

Shanxi Bethune Hospital研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.

适应症

Acute Lymphoblastic Leukemia, Adult

主动联系研究团队

总联系人（申办方／研究总部）

中国／港澳台研究中心

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
ClinicalTrials.gov Identifier: NCT07059156
Sponsor: Shanxi Bethune Hospital
Investigational product: Induction Therapy Regimen, Pre-Treatment Regimen, Post-CR Treatment, Post-CR Consolidation Regimens, Transplant-Eligible Subsequent Therapy

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
试验编号：NCT07059156
申办方：Shanxi Bethune Hospital
研究药物：Induction Therapy Regimen、Pre-Treatment Regimen、Post-CR Treatment、Post-CR Consolidation Regimens、Transplant-Eligible Subsequent Therapy

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 wangtao99699@163.com

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面