Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase 2 Feasibility Study of Sotrastaurin for Relapsed and Refractory CLL/SLL/PLL/RT
This phase II trial studies how well sotrastaurin acetate works in treating patients with chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation that has returned or that does not respond to treatment. Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the objective clinical response rate of AEB071 (sotrastaurin acetate)
treatment in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small
lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL)/Richter's transformation (RT).
SECONDARY OBJECTIVES:
I. To determine the feasibility and tolerability of long-term administration of a fixed dose
of AEB071 in patients with relapsed or refractory CLL/SLL/PLL.
II. To examine select downstream pharmacodynamic effects in this population of patients
after receiving AEB071 including assessment of the wingless-type MMTV integration site
family (WNT) signaling pathway.
III. To determine the feasibility and tolerability of AEB071 treatment in patients with
relapsed or refractory mantle cell lymphoma (MCL) as well as to gain preliminary data
regarding efficacy in this patient population.
TERTIARY OBJECTIVES:
I. Determine the proportion of patients with select germline and somatic deoxyribonucleic
acid (DNA) alterations, including in the B-cell receptor (BCR) pathway.
II. Determine how mutational and transcriptional status in key genes affects response to
this therapy and may have affected response to prior therapies.
OUTLINE:
Patients receive sotrastaurin acetate orally (PO) twice daily (BID) on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then at least
every 3 months thereafter.
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