Clinical Trial – Fludarabine/Clofarabine/Busulfan Combined With SAHA- Acute Leukemia

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

NCT number: NCT02083250

For enrollment please visit www.clinicaltrials.gov.

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