Skip to content

multi-center clinical study of CD19+ -car-t cells combined with chemotherapy in the treatment of the newly diagnosed high-risk adult PH (-) B-ALL

multi-center clinical study of CD19+ -car-t cells combined with chemotherapy in the treatment of the newly diagnosed high-risk adult PH (-) B-ALL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015164
Enrollment
Unknown
Registered
2018-03-11
Start date
2018-04-01
Completion date
Unknown
Last updated
2018-03-19

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

Conditions

newly diagnosed high-risk adult PH (-) B-ALL

Interventions

case series:CD19+CART cells+chemotherapy

Sponsors

Department of hematology, Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. newly diagnosed adult ph negative high-risk B-ALL patients with below condition; 2. Aged from 18 to 65 years; 3. ECOG score =2; 4. The Prognostic stratification at high risk, and the PH negative, not suitable for allogeneic stem cell transplantation or the rejection of allogeneic stem cell transplantation due to other reason; 5. No significant organ dysfunction.

Exclusion criteria

Exclusion criteria: 1) relapse ALL, CNS-ALL; 2) pregnant and lactating women; 3) participate clinical trials of other new drugs within 3 months; 4) abnormal liver and kidney function,which defined as 1.5 times higher than the upper limit of serum transaminase and bilirubin.Creatinine exceeds the normal upper limit; 5) patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Overall Surviva;Progress Free Survival;

Secondary

MeasureTime frame
Complete Response;minimal residual disease;toxic and adverse effects;

Countries

China

Contacts

Public ContactZhao mingfeng

Department of hematology, Tianjin First Central Hospital

mingfengzhao@sina.com+86 13752640369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026