Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VDCLP+V, 2VIP, Consolidation Therapy, Maintenance Therapy.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Adult. Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia
Overview
This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.
Detailed description
Adult Ph-negative ALL has inferior outcomes compared to childhood ALL. Pediatric-inspired regimens have improved survival in adolescent and young adult (AYA) patients. Venetoclax, a BCL-2 inhibitor, has shown preclinical sensitivity in Ph-negative ALL. Our center's previous IH-2022 regimen (a pediatric-inspired regimen combined with venetoclax protocol) showed promising efficacy and tolerability in adult patients.Immunotherapy is effective in ALL. This study aims to integrate immunotherapy into the pediatric-inspired backbone to optimize the regimen and improve survival outcomes.
Interventions
- Drug VDCLP+V
Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax. - Drug 2VIP
Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone. - Drug Consolidation Therapy
Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate. - Drug Maintenance Therapy
Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax. - Drug Blinatumomab
Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles. - Drug Venetoclax
Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol - Procedure CNS Prophylaxis
Intrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections. - Procedure CAR-T Cell Therapy
Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T. - Procedure Hematopoietic Stem Cell Transplantation (HSCT)
Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.
Primary outcome measures
- Event-Free Survival [Time frame: up to 5 years]
- MRD-negative CR rate by flow cytometry after induction regimen [Time frame: up to 6 weeks]
Secondary outcome measures (6)
- Complete Remission Rate [Time frame: up to 1 year]
- MRD-negative CR rate by flow cytometry at 12 weeks [Time frame: up to 12 weeks]
- MRD-negative CR rate by NGS at 12 weeks [Time frame: up to 12 weeks]
- Overall Survival (OS) [Time frame: Up to 5 years]
- Relapse-Free Survival (RFS) [Time frame: Up to 5 years]
- Cumulative Incidence of Relapse [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
- Age ≥14 years, ≤60 years
- ECOG performance status ≤2
- Adequate organ function (liver, kidney, cardiac)
- For patients of childbearing potential: use of effective contraception
- Willing and able to provide informed consent
Exclusion criteria
- Burkitt leukemia/lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or lactation
- Severe uncontrolled active infection
- History of pancreatitis
- Uncontrolled diabetes (HbA1c >7.5%)
- Active gastrointestinal bleeding within 6 months
- Arterial/venous thrombosis within 6 months
- Known HIV positivity
- Severe psychiatric illness hindering compliance
- Any other condition deemed unsuitable by the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07495631 · IIT2026003