A study to evaluate the effect of Atorvastatin in GvHD

Phase 3

• Conditions: Condition 1: Acute lymphoblastic leukemia [ALL]. Condition 2: Acute myeloid leukemia [AML].; Acute myeloblastic leukemia; c91.0; C92.0

• Registration Number: IRCT20140818018842N27
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Donor age : 18 years or above
Normal liver function in donors
Normal renal function in recipients
KPS =>60 for donors
Patients with a history of hematologic malignancies or bone marrow failure syndromes
Recipient age: 18 to 60 years
A fully HLA-matched family donor
LVEF=>40% for recipients
Normal liver function in recipients
Normal renal function in donors
KPS =>70 for recipients
There is no no prohibition for patients who already received Atorvastatin

Exclusion Criteria

Pregnant women and lactating mothers
Positive history of hypersensitivity to Atorvastatin in donors
HIV-positive donors
HIV-positive recipients
Positive history of hypersensitivity to Atorvastatin in recipients
Patients receiving ATG

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute GVHD. Timepoint: Weekly monitoring until 100 days after transplant. Method of measurement: Clinical assessment.;Oral mucositis. Timepoint: Weekly monitoring until 100 days after transplant. Method of measurement: Clinical assessment.

Secondary Outcome Measures

Name	Time	Method
Overall survival. Timepoint: Three years after transplantation. Method of measurement: Patient follow-up.;Disease-free survival. Timepoint: Three years after transplantation (1- 2 month intervals). Method of measurement: Clinical assessment.;Atorvastatin safety. Timepoint: Since 14 days before transplantation until 100 days after transplatation with 15-,30-,60- ,and 90-day intervals. Method of measurement: Clinical assessment as well as monitoring liver and muscle enzymes if necessary.