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Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

NCT03646123 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-08-28

Study results available
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Summary

This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C).

The drugs used in Part A are a combination of targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are called "A+AVD." Participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses).

Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening.

Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD." Parts B and C will study how well the drugs work to treat cHL and what side effects they cause.

Conditions

Interventions

DRUG

brentuximab vedotin

1.2 mg/kg by IV infusion

DRUG

doxorubicin

25 mg/m\^2 by IV infusion

DRUG

vinblastine

6 mg/m\^2 by IV infusion

DRUG

dacarbazine

375 mg/m\^2 by IV infusion

DRUG

G-CSF

Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD

DRUG

nivolumab

240 mg by IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2022-11-07
Completion
2024-08-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03646123 on ClinicalTrials.gov