M.D. Anderson Cancer Center is running a clinical trial to test drugs called Fludarabine, Clofarabine, Busulfan, SAHA and Thymoglobulin and a procedure called Stem Cell Infusion (SCT). The goal of this clinical research study is to evaluate the safety of combining vorinostat (also called SAHA) with fludarabine, clofarabine, and busulfan.
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
This is an investigational study. Fludarabine, clofarabine, and vorinostat are FDA approved and commercially available for the treatment of cancer. Busulfan is also FDA approved for use with stem cell transplants. The use of these drugs together with a stem cell transplant is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
The drugs are Fludarabine, Clofarabine, Busulfan, SAHA and Thymoglobulin and the procedure is Stem Cell Infusion (SCT).
| Study Type : |
Interventional (Clinical Trial) |
| Estimated Enrollment : |
72 participants |
| Intervention Model: |
Single Group Assignment |
| Masking: |
None (Open Label) |
| Primary Purpose: |
Treatment |
| Official Title: |
Fludarabine/Clofarabine/Busulfan Combined With SAHA in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia |
| Actual Study Start Date : |
March 2014 |
| Estimated Primary Completion Date : |
March 2020 |
| Estimated Study Completion Date : |
March 2021 |
Contacts
| Contact: Partow Kebriaei, MD |
713-745-0663 |
NCT Number
For enrollment please visit www.clinicaltrials.gov.
