Phase 2 N=21 Treatment

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

Previously Untreated Peripheral T-cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT03542266 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

May 2021

Primary outcome: Primary: Complete Response Rate — 75 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CC-486 Administration (Drug); CHOP Administration (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Mar 2020

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.