Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT07059156
Brief Summary:
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.
Detailed Description:
1\. Intervention Measures 1.1 Induction Therapy Regimen
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 1.2 Pre-Treatment Regimen
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. 1.3 Post-CR Treatment
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.
1.4 Post-CR Consolidation Regimens
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).
* 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). 1.5 Transplant-Eligible Subsequent Therapy
* 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).
1.6 Allo-HSCT Protocol 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.
1.7 Non-Transplant Maintenance Therapy
Options:
* 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).
* 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.\*
Study:
NCT07059156
Study Brief:
Protocol Section:
NCT07059156