RecruitingPhase 2Phase 3NCT07059156

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia

Sponsor

Shanxi Bethune Hospital

Enrollment

50 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, Adult

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination chemotherapy and bone marrow/stem cell transplantation protocol for adults with newly diagnosed acute lymphoblastic leukemia (ALL), a fast-growing blood cancer. The goal is to improve survival rates using an updated treatment regimen based on the most current Chinese clinical guidelines. **You may be eligible if...** - You are between 18 and 60 years of age - You have been newly diagnosed with acute lymphoblastic leukemia (ALL) confirmed by comprehensive testing (morphology, immunology, genetics, and molecular tests) - Your leukemia meets specific diagnostic criteria under WHO 2022 guidelines - You are well enough to receive intensive chemotherapy **You may NOT be eligible if...** - You have previously received treatment for ALL - You have other active cancers - You have serious organ problems (heart, liver, kidney) that make intensive chemotherapy unsafe - You are pregnant or breastfeeding - You have an active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInduction 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

DRUGPre-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.

OTHERPost-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.

DRUGPost-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).

OTHERTransplant-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).

OTHERAllo-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.

OTHERNon-Transplant Maintenance Therapy Options