Follicular Lymphoma Clinical Trial
Official title:
A Phase I/Ib Study of Alisertib Plus R-EPOCH for Treatment of Myc-Positive Aggressive B-Cell Lymphomas
This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD,
which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor
alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin,
vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large
B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for Myc
gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle of
R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL population
will be opened to further characterize clinical activity and safety.
Secondary objectives include estimates of complete response rate (CR) and progression free
survival (PFS). We will also explore for associations between baseline kinome signatures
and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to and
during treatment.
n/a
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