NCT07495631 Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
| NCT ID | NCT07495631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Lymphoblastic Leukemia, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 43 participants in total. It began in 2026-04-08 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07495631 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 60 Years, studying Acute Lymphoblastic Leukemia, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07495631 currently recruiting?
Yes, NCT07495631 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT07495631 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07495631 clinical trial?
NCT07495631 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 43 participants.
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