Acute Lymphoblastic Leukemia
Conditions
Interventions
Huaxi Protocol-2024):Stratified treatment guided by multi-method MRD detection: induction chemotherapy with dasatinib/olverembatinib plus VP regimen, followed by sequential chemotherapy and multiple c
Huaxi Protocol-2016:Induction chemotherapy with dasatinib plus VP regimen +/- all-trans retinoic acid. After complete remission, receive age-stratified consolidation chemotherapy. Select HSCT, immunot
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Subjects must meet the WHO 2016 diagnostic and classification criteria for Ph+ ALL. They must be newly diagnosed with Ph+ ALL and have not received any prior systemic anti-leukemia therapy; 3. Life expectancy of at least 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score <= 2;
Exclusion criteria
Exclusion criteria: 1. A prior history of chronic myeloid leukemia (CML), or a diagnosis of lymphoid blast phase of chronic myeloid leukemia; 2. Clinical manifestations of central nervous system leukemia (CNSL) or extramedullary infiltration of ALL, excluding lymphadenopathy or hepatosplenomegaly; 3. Active fungal, bacterial, or viral infections requiring systemic treatment, including but not limited to HIV (antibody-positive), active hepatitis B or C virus infection, or being in the active phase of a COVID-19 infection (subjects who received a COVID-19 vaccine or other live attenuated vaccine more than 28 days prior to enrollment may be enrolled); 4. Contraindications to the use of corticosteroids; 5. Deemed by the investigator to be unsuitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);MRD negativity rate at 1 month, 3 months, and 6 months post-induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Event-Free Survival (EFS);Overall Response Rate (ORR);Duration of MRD Negativity;Duration of CR, CRh, or CRi;Time to MRD Negativity;Time to CR, CRh, or CRi;Time to Treatment Failure (TTF);Safety Endpoints; | — |
Countries
China
Contacts
Public ContactYu Wu
West China Hospital of Sichuan University
Outcome results
None listed