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

Weill Cornell Medicine (WCM)

Status and phase

Completed

Phase 2

Conditions

Previously Untreated Peripheral T-cell Lymphoma

Treatments

Drug: CHOP Administration

Drug: CC-486 Administration

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03542266

1711018777

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.