drugset / Trial / NCT01629511

Allogeneic Stem Cell Transplant for CLL

NCT01629511

SequentialOpen-labelTreatment

Summary

This phase I/II trial studies the best dose and side effects of gemcitabine and how well it works with clofarabine and busulfan and donor stem cell transplant in treating participants with chronic lymphocytic leukemia. Drugs used in chemotherapy, such as gemcitabine, clofarabine, and busulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Timeline

Start
2012-11-21
Primary completion
2018-04-25
Completion
2018-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Intravenous
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Background Busulfan Small molecule Intravenous
Background Clofarabine Other / unclassified Intravenous
Background Methotrexate Small molecule Intravenous
Background Tacrolimus Small molecule Oral
Background filgrastim Protein / enzyme biologic Subcutaneous