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Use of atorvastatin in bone marrow transplantation

Evaluation of progenitor cell mobilizing effect of atorvastatin in autologous hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014071418484N1
Enrollment
44
Registered
2015-03-09
Start date
2013-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Follicular lymphoma. Condition 2: Hodgkin lymphoma. Condition 3: Non-follicular lymphoma. Condition 4: Multiple myeloma and malignant plasma cell neoplasms. Follicular lymphoma Hodgkin lymphoma Non-follicular lymphoma Multiple myeloma and malignant plasma cell neoplasms

Interventions

Intervention 1: Intervention: Atorvastatin 40 mg daily PO started from the first day of hospitalization and continued until the day of cell harvest plus standard filgrastim regimen. Intervention 2: Co
Treatment - Drugs
Placebo
Intervention: Atorvastatin 40 mg daily PO started from the first day of hospitalization and continued until the day of cell harvest plus standard filgrastim regimen
Control: Placebo once daily PO started from the first day of hospitalization and continued until the day of cell harvest plus standard filgrastim regimen

Sponsors

Vice Chancellor for Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 139 Years

Inclusion criteria

Inclusion criteria: Major inclusion criteria: Age equals to or greater than 18; Primary diagnosis consist of Hodgkin's lymphoma, Non-Hodgkin's lymphoma or Multiple Myeloma; Patient endorsement of informed consent Major exclusion criteria: Patients taking any statin drug at the time of enrollment; Occurrence of suspected drug related toxicity during treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean number of hematopoietic progenitor cells per microliter of peripheral blood. Timepoint: Baseline, at the time of cell harvest. Method of measurement: Number of cells by flowcytometry assessment.

Secondary

MeasureTime frame
Time of platelet recovery. Timepoint: Any time after transplantation in which platelet engraftment occurs. Method of measurement: Complete blood count test.;Time of polymorphonuclear recovery. Timepoint: Any time after transplantation in which polymorphonuclear recovery occurs. Method of measurement: Complete blood count test.;Occurrence of bleeding episodes. Timepoint: Any time after transplantation and before discharge. Method of measurement: Occurrence or non.;Occurrence of infection episodes. Timepoint: Any time after transplantation and before discharge. Method of measurement: Occurrence or non.;Mean dose of filgrastim for stem cell mobilization. Timepoint: Before cell harvest. Method of measurement: Sum of administered doses.;Mean dose of filgrastim for engraftment. Timepoint: After transplantation until discharge. Method of measurement: Sum of administered doses.;Duration of hospitalization. Timepoint: From the day of stem cell infusion until the day of discharge. Method of measurement: Number of days.;Mortality. Timepoint: From the day of stem cell infusion until the day of discharge. Method of measurement: Occurrence or non.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMolouk Hadjibabaie

Research Center for Rational Use of Drugs

Hajibaba@tums.ac.ir+98 21 8881 4157

Outcome results

None listed

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