CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
- 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
- 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.
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
NYP / Weill Cornell Medical Center
- Primary ID 1711018777
- Secondary IDs NCI-2019-03474
- Clinicaltrials.gov ID NCT03542266