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Clinical Trial 19952

Cancer Type: Malignant Hematology
Interventions:Adriamycin (doxorubicin); CC-486 (Azacitidine (Oral)); Vincristine; cyclophosphamide; cytoxan (cyclophosphamide); doxorubicin; prednisone

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Lubomir Sokol

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Multi-center Phase II Study of CC486-CHOP in Patients with Previously Untreated Peripheral T-cell 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.

Objective

Primary Objective: To determine the complete response rate (CR) of CC486-CHOP in PTCL by 2014 International Working Group (IWG) criteria, and the Deauville Criteria for scan interpretation. CR rate after cycle 6 will be used for the purpose of interim efficacy analysis. Secondary Objectives: To determine overall response rate (ORR), safety, survival (progression-free survival and overall survival), and time to next treatment.

Inclusion Criteria

  • Histologically confirmed diagnosis of PTCL of the following subtypes: (1) Angioimmunoblastic T-cell lymphoma (2) Follicular T-cell lymphoma (3)PTCL/NOS, T-follicular helper (TFH) variant
  • 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.