CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Condition: Previously Untreated Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

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 PTCL who have received no prior systemic therapy. The study
      has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.
    

Detailed description: 
      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.
    

Intervention name(s): CC-486 Administration; CHOP Administration
Intervention type(s): Drug; Drug
Intervention description(s): CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.; CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
Other intervention name(s): Oral Azacitidine
Intervention MeSH terms: Azacitidine; Cc-486
Intervention model: Single Group Assignment
Intervention model description: This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral T-cell Lymphoma; Azacitidine; Lymphoma