At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Advanced, Gleevec Refractory Chronic Myeloid Leukemia. A Randomized Phase II Study.
In Brief
A Phase 2 clinical trial evaluating Clofarabine, Busulfan, and 4 other interventions for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.
Study Details
Timeline
Interventions
Day -6 to Day -3 for Arm 1 = 10 mg/m\^2 intravenous (IV) Daily; Arm 2 = 20 mg/m\^2 IV Daily; Arm 3 = 30 mg/m\^2 IV Daily; Arm 4 = 40 mg/m\^2 IV Daily
Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily; Arm 4: 40 mg/m\^2 IV Daily. Test dose Day -8 32 mg/ m\^2 IV over 45 min, rest on Day -7.
Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily
Day 0 stem cell infusion (Bone marrow or peripheral blood progenitor cells (PBPC))
Day -3 to Day -1 at 0.5 mg/kg IV on Day -3; 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1.
Subcutaneous injection daily, starting 1 week after Stem Cell Transplant.