ALL. Acute lymphoblastic leukaemia [ALL]
Conditions
Interventions
Intervention 1: group A will be treated with UDCA 20 mg/kg in 2-3 divided doses daily for 6 months. The safety of the drug in terms of tolerance and possible side effects as well as its efficacy in pr
Treatment - Drugs
group A will be treated with UDCA 20 mg/kg in 2-3 divided doses daily for 6 months. The safety of the drug in terms of tolerance and possible side effects as well as its efficacy in preventing rise of
Patients entering group B will be treated with Vitamin E 400 IU daily for 6 months. Again, the safety of the drug and its hepatoprotective efficacy will be assessed.
Group C consists patients who will be provided with UDCA and Vitamin E simultaneously with the doses mentioned in previous arms. the duration of intervention is 6 months, and the efficacy and safety o
Patients classified as group D will serve as the control group, as they will not be treated with any new drug except their conventional chemotherapy drugs.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: All patients with documented diagnosis of acute lymphoblastic leukemia under age 18 years old who are on maintenance therapy are included. Those patients with pre existing established liver disease including liver cirrhosis or liver fibrosis are excluded from the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver enzymes. Timepoint: Monthly for 6 months. Method of measurement: LFT(Liver Function Tests). | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver echogenicity. Timepoint: At the beginning and at the end of treatment. Method of measurement: Liver ultrasonography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Bordbar
Shiraz University pof Medical Sciences
Outcome results
None listed