Evaluation of the effect of L-carnitine on the prevention of PEG-Asparaginase-induced hepatitis in patients with acute lymphoblastic leukemia

Evaluation of the effect of L-carnitine on the prevention of PEG-Asparaginase-induced hepatitis in patients with acute lymphoblastic leukemia

Clinical trial with a control group/double-blind and randomized.

Patients with acute lymphoblastic leukemia admitted to the pediatric oncology department and treated with PEG-Asparaginase. In the intervention group, L-carnitine is administered to patients from the second day of hospitalization until 14 days after receiving PEG-Asparaginase. The studied patients and the patient's caregivers are not aware of the type of drug used in each patient-episode.

Inclusion Criteria : 1-Patients from 1 month to 18 years old with acute lymphoblastic leukemia of B cells hospitalized in the oncology department of BouAliSina Hospital treated with COG protocol. 2-The normal level of liver enzymes at the beginning of the study. Exclusion Criteria: 1-lack of satisfaction 2-underlying liver disorder 3-underlying metabolic disorder involving the liver 4-Having viral hepatitis 5-taking hepatotoxic drugs 6-An increase in bilirubin or an increase in liver transaminases above normal values ​​before starting the study 7-Contraindication or allergy to L-carnitine

A double-blind study on children from one month to 18 years old with B-cell acute lymphoblastic leukemia who are treated with PEG-Asparaginase in the induction phase of the treatment protocol.In the intervention group, L-carnitine at a dose of 50 mg/kg/day every 12 hours is administered orally to patients from the second day of hospitalization until 14 days after receiving PEG-Asparaginase. In the control group, from the second day of hospitalization to the 14th day after receiving asparaginase, placebo is given every 12 hours.

Total Bill, Direct Bill, ALT, AST, ALK-P, PT, PTT, FBS, BUN, Cr, Uric Acid

We divide each client into two groups using a random table. This table is a set of numbers. Consider the numbers 1 to 19 for intervention A and the numbers 20 to 38 for control B (for both size groups larger and smaller than 4 cm). Then we touch one of the numbers and move into one of the predetermined directions and record the numbers and assign them to one of the groups. In this way, patients are divided completely randomly.

On the pharmaceutical form and the main drug, which is prepared by the project's pharmaceutical team, stickers containing Latin numbers and letters are attached, and these numbers and letters are recorded secretly. Medicines and placebos are delivered to the department. When it is necessary to prescribe medicine, with the coordination of the project executive resident (who is not aware of the type of medicine or placebo), the medicine is given to the patient randomly. The tag number is recorded in the data collection form. In the studies, the type of preparation of the drug or placebo is determined based on the equality of registration of labels and forms. The resident who implements the plan and the patient and the patient's parents will not have any information about the contents of the plan.