Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies

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.

Conditions

• Aggressive 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

Interventions

DRUG

Atorvastatin Calcium

Given PO

DRUG

Cyclosporine

Given PO

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mycophenolate Mofetil

Given PO or IV

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo nonmyeloablative allogeneic PBSC transplant

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo nonmyeloablative allogeneic PBSC transplant

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Marco Mielcarek · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-25

Primary Completion

2018-10-31

Completion

2019-04-30

FDA Drug

Yes

Countries

• United States

Study Locations