CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Atorvastatin Calcium +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01527045
NCT01527045Phase 2Completed
CompareCT.gov

Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation

Fred Hutchinson Cancer Center·interventional·Posted Feb 6, 2012·Updated Jan 2, 2020

In Brief

A Phase 2 clinical trial evaluating Atorvastatin Calcium, Cyclosporine, and 6 other interventions for Aggressive Non-Hodgkin Lymphoma and 20 related conditions. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

This phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAggressive Non-Hodgkin Lymphoma, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Lymphocytic Leukemia, Loss of Chromosome 17p, Myelodysplastic/Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Aggressive Adult Non-Hodgkin Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2012
Enrollment StartSep 25, 2012
Primary CompletionOct 1, 2018
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.4 years ago

Interventions

Atorvastatin Calciumdrug

Given PO

Cyclosporinedrug

Given PO

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO or IV

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo nonmyeloablative allogeneic PBSC transplant

Peripheral Blood Stem Cell Transplantationprocedure

Undergo nonmyeloablative allogeneic PBSC transplant

Total-Body Irradiationradiation

Undergo TBI