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Recruiting Phase 2 / Phase 3

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

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About this study

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.

Condition
Acute Lymphoblastic Leukemia, Adult
Tested
Induction Therapy Regimen, Pre-Treatment Regimen, Post-CR Treatment, Post-CR Consolidation Regimens, Transplant-Eligible...
Sponsor
Shanxi Bethune Hospital

Who can join

Age
18 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 60 years
  • Study condition: Acute Lymphoblastic Leukemia, Adult
  • Age: 18 to 60 years；
  • 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)；
  • ECOG Performance Status: 0-2

Exclusion 4

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

Where

1 site, 1 recruiting

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.