A 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
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: III
Principal Investigator: Vose, Julie
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02443077#eligibility
Summary
PRIMARY OBJECTIVES:
I. To evaluate the ability of ibrutinib to improve 24-month progression free survival (PFS) compared to placebo.
SECONDARY OBJECTIVES:
I. To evaluate the ability of ibrutinib to improve overall survival (OS) compared to placebo.
II. To evaluate the ability of ibrutinib to improve progression free survival (PFS) compared to placebo.
III. To evaluate the ability of ibrutinib to improve post-transplant response rates compared to placebo.
IV. To evaluate time to hematopoietic recovery in the two arms. V. To evaluate the safety and tolerability of ibrutinib compared to placebo. VI. To evaluate the incidence of secondary malignancies in the two arms. VII. To evaluate immune reconstitution in the two arms.