Pediatric-style chemotherapy with venetoclax and immunotherapy for adults with Ph-negative acute lymphoblastic leukemia
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
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT07495631 · Data updated 2026-11-12
This treatment plan tests whether pediatric-style chemotherapy combined with venetoclax and optional immunotherapy helps people aged 14–60 with newly diagnosed Ph-negative ALL achieve remission and clear minimal residual disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 60 Years |
| Sex | All |
| Enrollment | 43 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | April 8, 2026 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2030 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07495631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 14–60 with newly diagnosed, previously untreated Ph-negative ALL, ECOG ≤2, adequate organ function, and willingness to provide informed consent and use contraception if applicable.
✕Probably not a fit
Patients with Burkitt leukemia/lymphoma or ambiguous-lineage leukemia, active uncontrolled infections, pregnancy or lactation, severe comorbidities (including uncontrolled diabetes or recent thrombosis), known HIV positivity, or other investigator-deemed contraindications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, non-randomized prospective cohort that gives a pediatric-inspired chemotherapy backbone (IH-2014-based) combined with the BCL-2 inhibitor venetoclax and optional immunotherapy (including blinatumomab) to adults aged 14–60 with newly diagnosed Ph-negative ALL. Treatment follows standard phases—induction, consolidation, early and delayed intensification, and maintenance—with the number of immunotherapy cycles chosen based on patient preference. Primary endpoints are event-free survival and MRD-negative complete remission after induction measured by flow cytometry and next-generation sequencing, and secondary endpoints include CR rate, 12-week MRD-negativity, overall and relapse-free survival, and cumulative relapse rate. The study is performed at the Blood Diseases Hospital in Tianjin and excludes patients with certain leukemia subtypes, severe uncontrolled comorbidities, active infection, pregnancy, or other conditions that would impair safety or adherence.
Why it matters
Potential benefit: If successful, this combined approach could raise MRD-negative remission rates and improve event-free and overall survival for adults with Ph-negative ALL.
How similar studies have gone: Pediatric-inspired regimens have improved outcomes in adolescents and young adults and immunotherapies like blinatumomab have proven effective in ALL, while venetoclax shows preclinical and early clinical promise, but combining all three elements in this way is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Hui Wei, Doctor
- Email: weihui@ihcams.ac.cn
- Phone: 13132507161
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.