Combining a pediatric treatment approach with Venetoclax for young and adult patients with a specific type of leukemia
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
This study is testing a new treatment plan that combines a pediatric approach with Venetoclax to see if it helps teenagers and adults with a specific type of leukemia achieve better recovery and reduce the chance of relapse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05660473 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a pediatric-inspired treatment regimen combined with Venetoclax for adolescents and adults diagnosed with de novo Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL). The study aims to improve the rate of minimal residual disease (MRD)-negative complete remission after the initial treatment phase and to reduce the likelihood of relapse, thereby enhancing overall survival rates. Participants will receive a combination of chemotherapy agents including Vincristine, Daunorubicin, Cyclophosphamide, Pegaspargase, and Prednisone, alongside Venetoclax, which is known for its role in targeting B-cell lymphoma. The trial is designed for patients aged 14 to 60 years who meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults aged 14 to 60 years with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia.
Not a fit: Patients with Burkitt lymphoma/leukemia or acute leukemia of ambiguous lineage, as well as pregnant women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve remission rates and overall survival for patients with a challenging form of leukemia.
How similar studies have performed: While the combination of pediatric-inspired regimens with Venetoclax is a novel approach, preliminary studies suggest potential effectiveness in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification * Age: 14 -60 years * Male or female * ECOG Performance Status 0-2 * Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%; * Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: * Burkitt lymphoma/leukemia * Acute Leukemia of Ambiguous Lineage * Female patients who are pregnant or breast feeding * Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment * History of pancreatitis * Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded * History of active gastrointestinal bleeding within the last 6 months * History of arterial/venous thrombosis within the last 6 months * Known HIV seropositivity * Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Jianxiang Wang, Dr — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Jianxiang Wang, Dr
- Email: wangjx@ihcams.ac.cn
- Phone: 86-22-23909120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.