Relapsed and refractory ALK+ anaplastic large cell lymphoma in children
Conditions
Interventions
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed as ALK-positive anaplastic large-cell lymphoma (FISH, IHC, RT-PCR or NGS testing confirmed ALK-positive during the screening period); patients with tumor progression or recurrence during chemotherapy. 2. There is a traceable medical history record during treatment; 3. The subject has at least one measurable target lesion; 4. Age 1-18 years old; 5. Patients under the age of 18 have self-knowledge and can sign informed and voluntary consent forms; 6. The guardian of the child patient and/or the patient over 10 years old sign the informed and voluntary consent form to join this trial.
Exclusion criteria
Exclusion criteria: 1. Diagnosed as primary skin ALCL; 2. With other types of malignant tumors; 3. Unconsciousness; 4. Symptomatic heart failure or persistent arrhythmia = Grade 2, any degree of poorly controlled atrial fibrillation or QTc interval> 500ms; or myocardial infarction, severe/unstable angina, coronary artery/peripheral Arterial bypass graft, congestive heart failure, cerebrovascular accident, including transient ischemic attack; 5. Respiratory failure; 6. The subject has liver cirrhosis; or the subject has an elevated transaminase level IV and above; 7. Diffuse intravascular coagulation; 8. Serum creatinine and/or urea nitrogen >=1.5 ULN; 9. Gastrointestinal dysfunction or gastrointestinal diseases that may affect drug absorption (such as ulcer disease, uncontrollable nausea, vomiting, diarrhea or poor absorption syndrome); 10. Sepsis or other infections that are difficult to control; 11. Active hepatitis (hepatitis B: HBsAg or HBeAb positive, and HBV-DNA >=2000 IU/mL; hepatitis C: HCV antibody positive and HCV-RNA >=1000 IU/mL); HIV antibody positive; syphilis spiral antibody positive; 12. Uncontrollable diabetes; 13. Previously or currently diagnosed with severe mental disorders; 14. Pregnant and lactating women; 15. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the subject or affect the completion of the study, which may increase research-related risks, may interfere with the interpretation of the research results, or the investigator believes that it is not Suitable for subjects enrolled in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactYonghong Zhang
Beijing Boren Hospital
Outcome results
None listed