Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02250937

Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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 compare how well two different schedules of giving busulfan with fludarabine and cladribine before a stem cell transplant in patients with AML or MDS may help to control the disease. The safety of this drug combination will also be studied.

Status: 
Recruiting
Study Date: 
Wed, 10/01/2014 to Tue, 10/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Busulfan Arm 1 - Busulfan 80 mg/m2 (PK Studies) on Day -13 and Day -12. Arm 2 - Busulfan 80 mg/m2 (PK Studies) on Day - 20 and Day -13. Both Arms - Busulfan administered after Cladribine at dose calculated to achieve a total (including first two doses) systemic exposure of 20,000 ± 12% µMol-min based on pharmacokinetic studies on Days -6 to -3. Other Names: Busulfex Myleran Drug: Fludarabine Arm 1 and 2 - Fludarabine 10 mg/m2 on Days -6 through -3. Other Names: Fludarabine Phosphate Fludara Drug: Cladribine Both Arms - Cladribine 10 mg/m2 administered after Fludarabine on Days -6 through -3. Other Names: Leustatin 2-CdA Procedure: Stem Cell Transplant Both Arms - Stem cell transplant on Day 0. Drug: G-CSF Both Arms - G-CSF 5 mcg/kg/day subcutaneously on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 x 109/L for 3 consecutive days. Other Names: Filgrastim Neupogen Drug: Methotrexate Both Arms - Methotrexate 5 mg/m2 on Days +1, +3, +6, and +11 post bone marrow transplant.