CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

Study Summary:

This is a phase II, multi-center study to determine the efficacy and safety of first-line

CC-486 plus CHOP in patients with Peripheral T-cell Lymphoma (PTCL) who have received no

prior systemic therapy. The main objective is to determine the complete response rate

(CR) of CC486-CHOP in PTCL. CR rate after cycle 6 will be used for the purpose of interim

efficacy analysis.

- The study includes 6 cycles (~18 weeks) of treatment and 2 years of follow-up. The

projected end date is 12/31/2022. Patients achieving complete remission will be

evaluated every 6 months for 2 years or until disease progression. Patients who have

disease progression will be contacted every 6 months to assess for survival status.

- Standard dose CHOP will be provided on day 1 of each cycle and repeat every 3 weeks

for a total of 6 cycles.

- CC486 at 300 mg daily will be administered orally from day -6 to day 0 for cycle 1

priming, and on days 8-21 following cycles 1-5.

- Patients in CR/PR following 6 cycles of treatment have the option to proceed to

consolidative autologous stem cell transplant.

- Will continue on treatment as long as they are responding to therapy and not

experiencing unacceptable side effects.