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

Trial Status: Active

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.

Inclusion Criteria

  • Histologically confirmed diagnosis of PTCL of the following subtypes:
  • Angioimmunoblastic T-cell lymphoma
  • Follicular T-cell lymphoma
  • 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.

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
NYP / Weill Cornell Medical Center

  • Primary ID 1711018777
  • Secondary IDs NCI-2019-03474
  • Clinicaltrials.gov ID NCT03542266