50
Participants
Start Date
June 1, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
July 31, 2027
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"
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."
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."
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).~ 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
"* 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
"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
"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.\*"
RECRUITING
Shanxi Bethune Hospital, Taiyuan
Shanxi Bethune Hospital
OTHER