CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Nivolumab +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03586999
NCT03586999Phase 2Completed

Nivolumab With Standard of Care Chemotherapy for the First Line Treatment of Peripheral T Cell Lymphoma

University of Colorado, Denver·interventional·Posted Jul 16, 2018·Updated Oct 29, 2024

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Etoposide, and 4 other interventions for Peripheral T Cell Lymphoma. Completed, enrolled 18 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 16, 2018
Enrollment StartNov 7, 2018
Primary CompletionMay 26, 2021
Study CompletionSep 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.0 years ago

Interventions

Nivolumabdrug

Nivolumab injection is to be administered as an IV infusion.

Etoposidedrug

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.

Prednisolonedrug

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.

Oncovindrug

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.

Cyclophosphamidedrug

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.

Hydroxydaunorubicindrug

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.