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CD19 CAR T–cell therapy for relapse or refractory B-cell Lymphoma and acute B lymphocytic leukemia

CD19 CAR T–cell therapy for relapse or refractory B-cell Lymphoma and acute B lymphocytic leukemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-16009862
Enrollment
Unknown
Registered
2016-11-14
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Relapse or refractory B-cell Lymphoma and acute B lymphocytic leukemia

Interventions

The group with autologous stem cell transplantation:autologous stem cell transplantation
Chemotherapy pretreatment group:Chemotherapy

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. the patient or his/her legal guardians must sign a consent form; 2. the patient ages 6 years to 60 years, a male or female; 3. the patient was diagnosed with B-cell lymphoma by pathology, histology and flow cytometry; 4. the patient has lesions which can be measured or evaluated; 5. main organs seem to be functioning well: Liver function: bilirubin=34.2umol/L; Renal function: Serum creatinine<220umol/L; Lung function: arterial oxygen saturation=95%; Heart function: LVEF=40%; 6. peripheral venous blood in patients flow smoothly; 7. Karnofsky score=60.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. patients who want to be pregnant in 1 year; 3. patients who can not use contraception in 1 year; 4. uncontrolled active infection with in 4 weeks; 5. active hepatitis B or hepatitis C virus infection; 6. HIV infected patients; 7. patients with other cancers diagnosised by pathology; 8. patients with serious autoimmune diseases or immunodeficiency; 9. patients who suffer from allergies; 10. patients who have taken part in other clinical tests within 6 weeks; 11. patients who use systemic steroids before treatment within 4 weeks; 12. patients who have a history of central nervous system disease; 13. patients who are addicted to some drugs; 14. patients who are not allowed to take part in the test(judged by the researchers).

Design outcomes

Primary

MeasureTime frame
The CAR - T cells infusion quantity and rate of transfection;Imaging or bone marrow test results;

Secondary

MeasureTime frame
Disease progression-free survival time;Overall survival;

Countries

China

Contacts

Public ContactDeng Qi

Tianjin First Central Hospital

kachydeng@hotmail.com+86 13612055872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026