Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

May 26, 2021

Study Completion Date

September 20, 2022

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.

Trial Locations (3)

19107

Thomas Jefferson University, Philadelphia

80045

University of Colorado Hospital, Aurora

91010

City of Hope Cancer Center, Duarte

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Colorado, Denver

OTHER