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Efficacy and safety of vinecra combined with Hyper-CVAD/MA (modified) in the treatment of Ph-negative acute lymphoblastic leukemia: an open, single-arm, multicenter clinical study

Efficacy and safety of Vinecra combined with Hyper-CVAD/MA (modified) in the treatment of Ph-negative acute lymphoblastic leukemia: an open, single-arm, multicenter clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105599
Enrollment
Unknown
Registered
2025-07-07
Start date
2023-10-12
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ph-negative acute lymphoblastic leukemia

Interventions

Experimental group (general risk/ high risk/ very high risk):Patients were given alternating treatment with Venecra +Hyper-CVAD and Venecra +MA for 4 cycles, and then given VMMP regimen for consolidat

Sponsors

The Affiliated Tai'an Central Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed Ph-negtive acute lymphoblastic leukemia untreated (except prednisone and hydroxyurea use) confirmed by cell morphology and immunophenotype; 2.Age >=14 years old, = 3 months; 5. Men and women who may give birth agree to and use effective contraceptive methods; 6. Main organ function assessment criteria: total bilirubin (TBIL) 45% as shown by cardiac color ultrasound; 7. Understand and sign the informed consent and agree to comply with the study requirements.

Exclusion criteria

Exclusion criteria: 1.Burkitt lymphoma leukemia; 2. Unknown series of acute leukemia; 3. Pregnant women; 4. severe uncontrolled active infection; 5. Patients with previous history of pancreatitis; 6. Poorly controlled diabetes, defined as a hemoglobin A1C value > 7.5%. It is not necessary to exclude patients with pre-existing but well-controlled diabetes; 7. Patients with a history of active gastrointestinal bleeding within the last 6 months; 8. History of arterial/venous thrombosis within the last 6 months; 9. Known serum HIV positive; 10. A mental illness that is likely to prevent the subject from completing treatment or giving informed consent; 11. Other situations deemed unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
overall survival rate;disease free survival;relapse free survival;cumulative relapse frequencies;treatment-related toxicity;

Countries

China

Contacts

Public ContactBai Guanchen; Teng Qingliang

The Affiliated Tai'an Central Hospital of Qingdao University

Baiguanchen@qdu.edu.cn+86 538 629 6301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026