Refractory/relapsed acute T lymphoblastic leukemia in children
Conditions
Interventions
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1) Acute T lymphocytic leukemia patients diagnosed with primary drug resistance on the expression of the tumor surface antigen CD5, recurrence of chemotherapy, persistent residual positive or relapse/refractory after allogeneic hematopoietic stem cell transplantation; 2) Male or female patients, aged 0-18 years (including 18 years old); 3) No severe allergies; 4) Physical fitness score 0-2 points; 5) Estimated survival time >= 60 days; 6) Bone marrow or peripheral blood or immunohistochemical CD5 positive; 7) Self-knowledgeable patients aged 8-18 voluntarily sign the informed consent form, and the legal representative (guardian) of the child patient under the age of 18 voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Intracranial hypertension or brain consciousness disorder; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) With other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7) Suffer from sepsis or other infections that are difficult to control; 8) Suffer from uncontrollable diabetes; 9) Severe mental disorder; 10) There are obvious intracranial lesions in head MRI examination; 11) Have received an organ transplant (excluding bone marrow transplant); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Pharmacokinetic index;Efficacy index; | — |
Countries
China
Contacts
Public ContactJing Pan
Beijing Boren Hospital
Outcome results
None listed