A study to evaluate the effect of Atorvastatin in GvHD

A study to evaluate the efficacy of Atorvastatin in the prophylaxis of acute graft-versus-host disease in allogeneic hematopoietic stem cell transplantation (HSCT)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N27

Enrollment

Registered

2022-12-03

Start date

2015-08-23

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Acute lymphoblastic leukemia [ALL]. Condition 2: Acute myeloid leukemia [AML]. Acute myeloblastic leukemia

Interventions

Intervention 1: Intervention group: In this group, Atorvastatin 40 mg (Abidi Pharmaceutical Co.) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 da

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactParsa Rostami

Tehran University of Medical Sciences

rostami.parsa@yahoo.com+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026