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PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Classical Hodgkin Lymphoma

NCT03226249 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-02

Study results available
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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.

Conditions

  • Classical Hodgkin Lymphoma
  • Lymphocyte-Depleted Classical Hodgkin Lymphoma
  • Lymphocyte-Rich Classical Hodgkin Lymphoma
  • Mixed Cellularity Classical Hodgkin Lymphoma
  • Nodular Sclerosis Classical Hodgkin Lymphoma

Interventions

PROCEDURE

Computed Tomography

Undergo FDG-PET/CT

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

RADIATION

Fludeoxyglucose F-18

Undergo FDG-PET/CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET/CT

DRUG

Vinblastine Sulfate

Given IV

Sponsors & Collaborators

Principal Investigators

  • Jane Winter, M.D. · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2019-05-17
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226249 on ClinicalTrials.gov