CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 30 enrolled
Drug / intervention
Dacarbazine +7 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/NCT03226249
NCT03226249Phase 2Unknown

Phase II Study of PET-Directed Frontline Therapy With Pembrolizumab and AVD for Patients With Classical Hodgkin Lymphoma

Northwestern University·interventional·Posted Jul 21, 2017·Updated Jun 2, 2023

In Brief

A Phase 2 clinical trial evaluating Computed Tomography, Dacarbazine, and 6 other interventions for Classical Hodgkin Lymphoma and 4 related conditions. Targeting 30 participants across 4 sites.

Detailed Summary

The purpose of this research study is to evaluate a new drug pembrolizumab in combination with chemotherapy, for the treatment of newly diagnosed Hodgkin lymphoma. The chemotherapy regimen is called AVD and includes three drugs: adriamycin, vinblastin, dacarbazine. Pembrolizumab is currently FDA approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Hodgkins Lymphoma. The AVD regimen of chemotherapy is currently FDA approved for the treatment of newly diagnosed Hodgkin lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a new diagnosis of Hodgkins Lymphoma, multi-agent chemotherapy is recommended. Also, for patients who do not have a complete response to chemotherapy (meaning there is still evidence of disease on PET scans performed at the end of treatment), radiation is sometimes recommended. Furthermore, the rare patient who relapses after chemotherapy requires treatment with high dose chemotherapy and a transplant.

Study Details

Timeline

Phase 2UnknownOverdue
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartNov 9, 2017
Primary CompletionMay 17, 2019
Study CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.9 years ago

Interventions

Computed Tomographyprocedure

Undergo FDG-PET/CT

Dacarbazinedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Fludeoxyglucose F-18radiation

Undergo FDG-PET/CT

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV

Positron Emission Tomographyprocedure

Undergo FDG-PET/CT

Vinblastine Sulfatedrug

Given IV