At a glance
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Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Busulfan, and 3 other interventions for Stem Cell Transplantation and Leukemia. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
Study Details
Timeline
Interventions
40 mg/m\^2 by vein over 60 minutes on Day -5 through Day -2.
Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).
2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.
Start cycles of 32 mg/m\^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.
Stem cell infusion on day 0 administered by vein after collected from donor.