Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype
The purpose of this study is to directly compare any good and bad effects of using an oral medication, ibrutinib, along with the AutoHCT versus AutoHCT alone.
Primary: To evaluate the ability of ibrutinib to improve 24-month progression free survival (PFS) compared to placebo. Secondary: To evaluate the ability of ibrutinib to improve overall survival (OS) compared to placebo. To evaluate the ability of ibrutinib to improve progression free survival (PFS) compared to placebo. To evaluate the ability of ibrutinib to improve post-transplant response rates compared to placebo. To evaluate time to hematopoietic recovery in the two arms. To evaluate the safety and tolerability of ibrutinib compared to placebo. To evaluate the incidence of secondary malignancies in the two arms. To evaluate immune reconstitution in the two arms.
Bone Marrow Transplant; Therapy (NOS)
748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib); Placebo ()
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