drugset / Trial / NCT01518153

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

NCT01518153

Phase 2 Terminated 16 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body. Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants: * Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. * Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die. * Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD). The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.

Timeline

Start
2012-02
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Background Alemtuzumab Monoclonal antibody 50 mg Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background G-CSF Unknown 5 ug/kg Subcutaneous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Methotrexate Small molecule 5 mg/m2 Intravenous
Background Tacrolimus Small molecule 0.015 mg/kg Intravenous