At a glance
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Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Busulfan, and 7 other interventions for Leukemia and Chronic Myelogenous Leukemia. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if giving a kind of immune cell called natural killer (NK) cells after chemotherapy will improve the response to a stem cell transplant in patients with CML. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
40 mg/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.
130 mg/ m2 by vein for 2 doses on Days -11 to -10.
Natural killer cell infusion will be administered by vein on Day -8.
0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.
2.5 mg/kg by vein for 3 doses on Days -3 to -1.
Allogeneic related stem cell transplant by vein on day 0.
Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.
5 mg/m2 by vein Days 1, 3 and 6 post transplant.
5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.