drugset / Trial / NCT01640301

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant

NCT01640301

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects of laboratory-treated T cells and to see how well they work in treating patients with high-risk acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelogenous leukemia (CML) that has returned after a period of improvement (relapsed), previously treated with donor stem cell transplant. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing. Placing a gene that has been created in the laboratory into a person's T cells may make the body build an immune response to kill cancer cells.

Timeline

Start
2012-12-06
Primary completion
2020-03-20
Completion
2020-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject WT1-Sensitized Allogeneic T-Lymphocytes Unknown Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous
Background aldesleukin Protein / enzyme biologic Subcutaneous