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

• Status: Active, not recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Celgene Corporation
• Treatments: Azacitidine; Cc-486

Criteria

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.