Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02083250

Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of this clinical research study is to evaluate the safety of combining vorinostat (also called SAHA) with fludarabine, clofarabine, and busulfan.

Status: 
Recruiting
Study Date: 
Sat, 03/01/2014 to Fri, 03/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Fludarabine 10 mg/m2 by vein on Days -6 to -3. Other Names: Fludarabine phosphate Fludara Drug: Clofarabine 40 mg/m2 by vein on Days -6 to -3. Other Names: Clofarex Clolar Drug: Busulfan Busulfan test dose, 32 mg/m2, administered within 10 days prior to admission as an outpatient or as an inpatient on Day -8. Busulfan pharmacokinetics performed with the test dose and the first dose on Day-6. Busulfan adjusted dose determined to achieve a systemic exposure represented by an average daily AUC of 5500 µMol-min ± 5% for the entire 4-day treatment period, Days -6 to -3. If pharmacokinetic analysis cannot be completed for any reason, Busulfan given in a dose of 130 mg/m2 daily. Other Names: Busulfex Myleran Drug: SAHA Starting dose of SAHA: 200 mg by mouth daily on Days -6 to -3, within one hour prior to fludarabine administration for total 4 doses. Other Names: Vorinostat Suberoylanilide Hydroxamic Acid MSK-390 Zolinza Procedure: Stem Cell Infusion (SCT) Stem cell infusion on Day 0. Drug: Thymoglobulin Participants who receive a graft from an unrelated donor receive 0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.0 mg/kg on day -1. Other Names: ATG Antithymocyte Globulin