Combined chemotherapy with venetoclax and stem cell transplant for adults with Ph-negative ALL

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

This trial will try a treatment plan that gives intensive chemotherapy including venetoclax, followed by consolidation chemotherapy and possible allogeneic stem cell transplant, for adults aged 18–60 with Philadelphia chromosome–negative acute lymphoblastic leukemia.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide, prednisone, blinatumomab, Basiliximab, Methotrexate
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT07059156 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm phase 2/3 protocol plans to enroll 50 newly diagnosed adults (18–60 years) with Ph-negative ALL. Induction uses the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone with an 8-day venetoclax ramp-up), followed by consolidation with either Hyper-CVAD or CAM regimens and allogeneic hematopoietic stem cell transplantation for eligible patients. MRD-guided decisions include blinatumomab for MRD-positive disease before transplant, and patients will be followed for two years with serial MRD and safety monitoring. Primary endpoints are disease-free survival and complete remission rate; secondary endpoints include relapse, overall survival, and adverse events.

Who should consider this trial

Good fit: Adults aged 18–60 with newly diagnosed Philadelphia chromosome–negative ALL, ECOG 0–2, who meet diagnostic criteria and are medically fit for intensive chemotherapy and potential allo-HSCT are ideal candidates.

Not a fit: Patients with Ph-positive disease, active intracranial hemorrhage, pregnancy, severe psychiatric or other conditions preventing protocol compliance, or who are not fit for intensive therapy or transplant are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this combined strategy could increase remission rates and extend survival by improving MRD clearance and consolidating remission with transplant.

How similar studies have performed: Combining intensive chemotherapy with allogeneic transplant is an established approach in adult ALL, but adding frontline venetoclax is relatively new with limited early data showing promise.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 to 60 years；
2. Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts/immature lymphocytes in bone marrow (Note: Patients with \<20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；
3. ECOG Performance Status: 0-2

Exclusion Criteria:

1. Intracranial hemorrhage
2. Pregnancy
3. Psychiatric disorders or other conditions compromising protocol compliance
4. Severe cardiac arrhythmia with ECG abnormalities (QTc \>500 ms)

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Tao Wang, Dr.

Conditions Acute Lymphoblastic Leukemia, Adult