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CART-19 recurrent or refractory source B cell acute lymphoblastic leukemia, single center of safety and effectiveness, single arm, open label, phase II clinical study

CART-19 recurrent or refractory source B cell acute lymphoblastic leukemia, single center of safety and effectiveness, single arm, open label, phase II clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018210
Enrollment
Unknown
Registered
2018-09-05
Start date
2018-09-05
Completion date
Unknown
Last updated
2018-09-10

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

Conditions

Refractory/recurrent B cell source acute lymphocytic leukemia.

Interventions

Case series:Cyclophosphamide: intravenous cyclophosphamide 0.8 1.0 g/m ^ 2 / day, infusion 2 days (4 to 5 days prior to cell infusion)
Fluorine dara marina: intravenous fluorine dara marina 25 mg/m ^ 2 / day, infusion three days (3 to 5 days before the cell infusion)

Sponsors

The First Affiliated Hospital of Xinxiang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 16 and 70 years, with a life expectancy of more than 3 months; 2) acute B lymphocytic leukemia diagnosed as CD19+; 3) KPS score >70 points; ZPS score is less than 2; 4) there is no effective treatment after the failure of transplantation of autologous stem cells or allogeneic stem cells, or recurrence after chemotherapy; 5) sufficient heart, liver, kidney, bone marrow function (heart: no heart disease or coronary heart disease, cardiac function: 1-2 level; Liver: total bilirubin is no more than 3 times normal value upper limit (ULN), aspartate aminotransferase (AST) is less than or equal to 2.5; 6) the upper limit of normal value, ALT no more than 2.5 times normal value upper limit; Kidney: Cr = 1.25 times normal value upper limit; Bone marrow: WBC is greater than or equal to 3.0 * 109/L, Hb is greater than 90 g/L, and PLT is greater than 80 * 10^9/L; 7) patients and family members agree to participate in the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) pregnant or lactating women (women of childbearing age need to have a pregnancy test); 2) serious infectious diseases or viral diseases (HIV positive, syphilis, etc.); 3) active b or c viral hepatitis; non-severe allergic constitution; 4) With other serious diseases (such as autoimmune diseases, immune deficiency and organ transplantation) that conflict with the programme; 5) With history of other malignant tumors; 6) With serious mental disorder; 7) patients who had used a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks; 8) patients with serious heart, liver, renal insufficiency, diabetes and other diseases; 9) transaminase > 2.5 times normal value upper limit, bilirubin > 3 times normal value upper limit, creatinine > 1.25 times normal value upper limit; 10) have participated in other clinical studies in the past 3 months, or have been treated by other gene products; 11) the researcher does not think it is appropriate to participate in the study, or other situations that may affect the analysis of the results of this clinical study.

Design outcomes

Primary

MeasureTime frame
Tiny residual, The bone marrow;

Countries

China

Contacts

Public ContactJing-Dong Li

the First Affiliated Hospital of Xinxiang Medical College

xykljd@163.com+86 18567569380

Outcome results

None listed

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