Burixafor (TG-0054) vs Plerixafor

NCT01018979 · Phase 2 · completed

Although this study assigned patients to two dose levels, it had no placebo or active-comparator arm and was fully open-label (no masking), so there was no control against which to judge the drug's effect. Only 19 patients were treated, and most (13 of 19) dropped out before completing collection because their stem cell counts never rose high enough, leaving just 4 and 3 patients per dose group who even underwent apheresis for the primary mobilization-success endpoint. With no control arm and such a small, high-dropout sample, this is uncontrolled, exploratory evidence rather than a definitive efficacy trial.

NCT00103662 · Phase 3 · completed

This was a randomized, quadruple-blinded, placebo-controlled Phase 3 trial with a reasonably large sample (302 patients) and a clinically meaningful primary endpoint (achieving a target stem cell yield within a defined apheresis window). Results were not posted at the time of grading; the key result shown was recorded subsequently from the registry record.