Tazemetostat Plus CHOP in 1L T-cell Lymphoma

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)

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Ipsen

  collaborator INDUSTRY

• Eric Jacobsen, MD

  lead OTHER

Principal Investigators

• Eric Jacobsen, MD · Dana-Farber Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-24

Primary Completion

2027-10-01

Completion

2032-10-01

FDA Drug

Yes