Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Acute Lymphoblastic Leukemia, Adult
Interventions
DRUG

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"

DRUG

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."

OTHER

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."

DRUG

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)."

OTHER

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)."

OTHER

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."

OTHER

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.\*"

Trial Locations (1)

030000

RECRUITING

Shanxi Bethune Hospital, Taiyuan

All Listed Sponsors
lead

Shanxi Bethune Hospital

OTHER

NCT07059156 - Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL | Biotech Hunter | Biotech Hunter