Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
Status:
Recruiting
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to learn if giving romidepsin before and after a
stem cell transplant in combination with fludarabine and busulfan can help to control
leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin
that can be given with this combination.
The safety of this combination and the safety of giving romidepsin after a stem cell
transplant will also be studied.
This is an investigational study. Romidepsin is FDA approved and commercially available for
the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole
body) therapy before. Busulfan and fludarabine are FDA approved and commercially available
for use with a stem cell transplant.
The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of
leukemia or lymphoma you have is considered investigational.
Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center Ohio State University Comprehensive Cancer Center