Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Jun 7, 2026
  • participants needed
    240
  • sponsor
    Seagen Inc.
Updated on 27 July 2021
cancer
graft versus host disease
lymphoma
white blood cell count
granulocyte colony stimulating factor
measurable disease
doxorubicin
colony stimulating factor
chemotherapy regimen
nivolumab
dacarbazine
vinblastine
brentuximab
classical hodgkin lymphoma

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.

Description

This study will have three parts.

Part A of the study is designed to evaluate the incidence of febrile neutropenia, efficacy, and dose intensity in participants with advanced stage classical Hodgkin lymphoma (cHL) receiving granulocyte colony stimulating factor primary prophylaxis (G-PP) administration during treatment with frontline A+AVD. In Part A, participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment. Participants will be treated using institutional standard of care practices for the majority of treatment decisions.

Part B is designed to evaluate the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) as frontline treatment in participants with advanced cHL. In Part B, participants will be given AN+AD combination for 6 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage II with bulky mediastinal disease and Stage III or IV cHL.

Part C is designed to evaluate AN+AD as frontline treatment in participants with early stage cHL. In Part C, participants will be given AN+AD combination for 4 cycles of treatment. This part of the trial will look at whether this combination of drugs is effective and tolerable in participants with Stage I or II cHL with non-bulky mediastinal disease.

Details
Condition Hodgkin's Disease, Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment G-CSF, doxorubicin, Nivolumab, dacarbazine, brentuximab vedotin, Vinblastine
Clinical Study IdentifierNCT03646123
SponsorSeagen Inc.
Last Modified on27 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Treatment-nave, classic Hodgkin lymphoma (cHL) participants
Participants enrolling in Part A of the study must have Ann Arbor Stage III or IV disease
Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cH: with bulky mediastinal disease, or Stage III or IV
Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease
Histologically confirmed cHL according to the current World Health Organization (WHO) Classification
Bidimensional measurable disease as documented by PET/CT or CT imaging
Age 12 years or older in the United States. For regions outside of the US, participants must 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria

Nodular lymphocyte predominant HL
History of another malignancy within 3 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk or metastasis or death. Participants with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Active cerebral/meningeal disease related to the underlying malignancy
Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
Current therapy with other systemic anti-neoplastic or investigational agents
Planned consolidative radiotherapy (Parts B and C only)
Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only)
Grade 3 or higher pulmonary disease unrelated to underlying malignancy
History of a cerebral vascular event within 6 months of first dose of study drug
Child-Pugh B or C hepatic impairment
Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
Grade 2 or higher peripheral sensory or motor neuropathy
Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
Previous treatment with brentuximab vedotin
Participants who are pregnant or breastfeeding
Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up
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