NCT06692452

Tazemetostat Plus CHOP in 1L T-cell Lymphoma

A Phase II Study of Tazemetostat in Combination With CHOP for Previously Untreated T Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eric Jacobsen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to evaluate tazemetostat in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as a possible treatment for peripheral T-Cell Lymphoma (PTCL). The name of the study drugs involved in this study are: * Tazemetostat (a type of inhibitor for Enhancer of Zeste Homolog 2 (EZH2)) * Standard of care CHOP therapy: * Cyclophosphamide (a type of alkylating agent) * Doxorubicin (a type of anthracycline antibiotic) * Vincristine (a type of vinca alkaloid) * Prednisone (a type of corticosteroid) * Standard of care BEAM conditioning regimen for autologous stem cell transplant: * Carmustine (a type of alkylating agent) * Etoposide (a type of Topoisomerase II inhibitor) * Cytarabine (a type of antineoplastic) * Melphalan (a type of alkylating agent)

Detailed description

This is a phase 2 open-label study of Tazemetostat plus CHOP chemotherapy to find out if the addition of Tazemetostat is more beneficial than the usual approach for PTCL, which is CHOP or CHOEP (CHOP with Etoposide) with a potential standard-of-care autologous stem cell transplant. Tazemetostat works to slow down and decrease specific proteins that may be overactive in PTCL. The U.S. Food and Drug Administration (FDA) has not approved tazemetostat for Peripheral T-Cell Lymphoma but it has been approved for other uses cancers including a different type of lymphoma called Follicular Lymphoma. The FDA has approved CHOP as a treatment option for PTCL. The research study procedures include screening for eligibility, in-clinic visits, blood tests, electrocardiograms (ECGs), echocardiograms (Echos), Positron Emission (PET) scans, Computerized Tomography (CT) scans, tumor biopsies, and bone marrow biopsies and aspirations. It is expected that about 24 people will take part in this research study. Ipsen is supporting this research study by providing the study drug, tazemetostat and funding.

Conditions

• Lymphoma
• Peripheral T Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tazemetostat	EZH2 inhibitor, 200 mg tablet, taken orally per protocol.
DRUG	Doxorubicin	Anthracycline antibiotic, 10, 20, 50, 100, and 200 mg vials, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Vincristine	Vinca Alkaloid, 1, 2, and 5mL vials, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Prednisone	Corticosteroid, 1, 2.5, 5, 10, 20, 25, and 50 mg tablets, taken orally per institutional standard of care.
DRUG	Cytoxan	Alkylating agent, 100mg, 200 mg, and 500mg vials, and 1 and 2 gram vials, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Carmustine	Alkylating agent, 100 mg single dose vials, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Etoposide	Topoisomerase II inhibitor, 100mg single dose vial, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Cytarabine	Antineoplastic, 20mg single dose vial, via intravenous, intrathecal, or subcutaneous injection per institutional standard of care
DRUG	Melphalan	Alkylating agent, 90 mg multi-dose vial, via parenteral infusion per institutional standard of care.

Timeline

• Start date: 2024-12-24
• Primary completion: 2027-10-01
• Completion: 2032-10-01
• First posted: 2024-11-18
• Last updated: 2026-04-01

Regulatory

• FDA-regulated drug study