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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanxi Bethune Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Tao Wang, Dr.
• Email: wangtao99699@163.com
• Phone: 13835175119

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.