Real-world Study on the DV-CAG regimen in T-ALL

Real-world Study on the Combination of CD38 Monoclonal Antibody, Venetoclax, and CAG Regimen in the Treatment of Acute T-Cell Lymphoblastic Leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110926

Enrollment

Unknown

Registered

2025-10-22

Start date

2025-10-24

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

t cell acute lymphoblastic leukemia

Interventions

DV-CAG treatment:DV-CAG combined treatment

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Known and written informed consent (ICF) voluntarily; 2. Diagnosed with acute T cell lymphoblastic leukemia according to 2022 WHO diagnostic criteria,blast with positive expression of CD38; 3. Age 15~65 years (including 15 and 65); 4. ECOG 0-2; 5. Expected survival time more than 3 months; 6. Adequate hepatic function: a) Serum creatinine 50%; c) Baseline blood oxygen saturation>96%; d) Total bilirubin <= 2 × ULN; ALT and AST <= 3 × ULN (determined by researchers, ALT and AST <= 5 × ULN due to elevated transaminases caused by ALL disease itself);

Exclusion criteria

Exclusion criteria: 1. Presence of other active malignant disease(With the exception of basal cell carcinoma of the skin and surgically resected papillary thyroid carcinoma); 2. Allergic to medicine(s) used in DV-CAG regimen; 3. Serious and or uncontrolled infections; 4. Severe heart disease; 5. With primary central nervous system disease:including cerebrovascular accident (CVA) or intracranial infection within the past 6 months; 6. Severe primary lung disease:including Patients with severe pulmonary ventilation-diffusion impairment and respiratory failure; 7. Severe primary liver / kidney disease; 8. Pregnancy, lactation; 9. History of other prior malignancies that may affect protocol adherence or interpretation of results; 10. Malabsorption syndromes or other conditions that impede the enteral route of drug delivery; 11. Patients who, in the judgment of the investigator, are not appropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
ratio of negative minimal residual disease;	—

Secondary

Measure	Time frame
allo-SCT rate;Adverse event rates;overall survival;event-free survival;progression free survival;	—

Countries

China

Contacts

Public ContactMi Jianqing

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

mjq10597@rjh.com.cn+86 21 6437 0045

Outcome results

None listed

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