Phase 2
Completed N=21
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Source: ClinicalTrials.gov NCT03542266 ↗Enrolled (actual)
21
Serious AEs
28.6%
Results posted
May 2021
Primary outcomePrimary: Complete Response Rate — 75 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate |
75 | — |
| SECONDARY Kaplan-Meier Overall Survival |
68.0 | — |
| SECONDARY Kaplan-Meier Progression-Free Survival |
65.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03542266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.