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
Intervention: CC-486 Administration; CHOP Administration
Intervention description: 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
Intervention MeSH terms: Azacitidine; Cc-486
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Peripheral T-cell Lymphoma; Azacitidine; Lymphoma

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.
    

Eligibility criteria:

        Inclusion Criteria:

        - Histologically confirmed diagnosis of PTCL of the following subtypes: Nodal T-cell
        lymphoma with T-follicular helper (TFH) phenotype (tumor cells must express 2 or 3
        TFH-related antigens, including PD1, CD10, BCL6, CXCL13, ICOS, SAP and CCR5)*
        Angioimmunoblastic T-cell lymphoma Follicular T-cell lymphoma PTCL/NOS, T-follicular helper
        (TFH) variant PTCL-NOS Anaplastic large cell lymphoma, ALK negative Anaplastic large cell
        lymphoma, ALK positive with IPI > 2 Adult T-cell leukemia / lymphoma

          -  No prior systemic therapy for lymphoma

          -  Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in
             two dimensions

          -  ECOG performance status ≤ 2

        Exclusion Criteria:

          -  Known central nervous system (CNS) involvement by lymphoma

          -  Active viral infection with HIV or hepatitis type B or C (seropositive HBV patients
             are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral
             therapy).

          -  Prior history of malignancies other than PTCL unless the patient has been disease free
             for ≥ 5 years from the signing of the ICF.