pediatric leukemia
Conditions
Interventions
treatment group:leucovorin as a rescue agent for HD-MTX
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Age: Participants must be older than 1 month and younger than 18 years of age. Diagnosis: Confirmed diagnosis of acute lymphoblastic leukemia (ALL), including both T-cell ALL (T-ALL) and B-cell ALL (B-ALL). Treatment History: Patients have received high-dose methotrexate (HD-MTX) therapy and have undergone monitoring of methotrexate blood levels. Informed Consent: Written informed consent has been obtained from the patient or legal guardian, and the patient is willing to comply with follow-up requirements.
Exclusion criteria
Exclusion criteria: Patients diagnosed with acute mixed lineage leukemia or acute undifferentiated leukemia according to WHO or EGIL criteria. Patients with chronic myeloid leukemia (CML) that has transformed into an acute lymphoblastic phase or other secondary leukemias. Patients with Down syndrome, or those with congenital, hereditary, or metabolic diseases accompanied by organ dysfunction. Patients who have participated in another drug clinical trial within 4 weeks prior to this study, where the previous trial could directly impact the current research. Patients with a confirmed allergy to leucovorin, methotrexate, and/or any of their excipients. Patients with a history of epilepsy or those taking oral antiepileptic medications. Patients deemed unsuitable for inclusion in the study by the investigator based on clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| MTX concentration;Proportion of Patients Experiencing Delayed Excretion; | — |
Countries
China
Contacts
Public ContactQi Peijing, Zhang Ruidong
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed