Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas

Part of paid clinical trials in Duarte, California.

Sponsor
University of Colorado, Denver
Study ID
NCT03586999
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab injection is to be administered as an IV infusion.
  • Etoposide — DRUG
    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.
  • Prednisolone — DRUG
    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.
  • Oncovin — DRUG
    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.
  • Cyclophosphamide — DRUG
    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.
  • Hydroxydaunorubicin — DRUG
    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.

Study Details

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

Key Dates

Start date
Nov 7, 2018
Status verified
Oct 2024
Primary completion
May 26, 2021
Completion
Sep 20, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and EPOCH
    Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.

Primary Outcome Measure

Efficacy: Complete Response Rate [ Time Frame: up to 100 days post transplant ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
University of Colorado HospitalAuroraColorado80045-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CAUniversity of Colorado Hospital· Aurora, COThomas Jefferson University· Philadelphia, PA

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