Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas

Summary

This regimen aims to become the first line treatment for peripheral T cell lymphoma, using nivolumab with the standard of care chemotherapy.

Conditions

• Peripheral T Cell Lymphoma

Interventions

DRUG

Nivolumab

Nivolumab injection is to be administered as an IV infusion.

DRUG

Etoposide

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

DRUG

Prednisolone

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

DRUG

Oncovin

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

DRUG

Cyclophosphamide

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

DRUG

Hydroxydaunorubicin

Dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using the Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a \>10% weight gain or loss. Patients receive six 21-day cycles of the medications.

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Brad Haverkos, MD · University of Colorado, Denver

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-07

Primary Completion

2021-05-26

Completion

2022-09-20

FDA Drug

Yes

Countries

• United States

Study Locations