drugset / Trial / NCT01027000

Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01027000

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Timeline

Start
2010-02
Primary completion
2016-01
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Methotrexate Small molecule Intravenous
Subject Rituximab Monoclonal antibody Intravenous
Subject Sirolimus Small molecule Oral
Subject Tacrolimus Small molecule Oral
Background Fludarabine Small molecule Intravenous

Indications