At a glance
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G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias
In Brief
A Phase 2 clinical trial evaluating Plerixafor, Filgrastim, and 4 other interventions for Stem Cell Transplantation and Leukemia. Completed, enrolled 47 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).
Study Details
Timeline
Interventions
Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses. Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I
Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days.
Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine.
Stem Cell Infusion (Bone marrow or PBPC)
Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.