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Closed (no longer recruiting)Last updated: 14 May 2024

This Phase II trial is evaluating how effective two different combinations of treatments including anticancer drugs, chemotherapy and immunotherapy, are at treating classical Hodgkin lymphomaMultiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Clinical summary

Summary

This is a non-randomised, parallel assignment study that has three parts. Part A involves the anticancer drug Brentuximab vedotin and chemotherapy drugs doxorubicin, vinblastine, and dacarbazine (this combination is also known as A+AVD) being administered separately via intravenous infusion (IV) to participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle. Participants in Part A will also be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment. Part B involves the anticancer drug Brentuximab vedotin, immunotherapy drug nivolumab, and chemotherapy drugs doxorubicin and dacarbazine (this combination is also known as AN+AD) being administered separately via IV to participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle. Part C involves AN+AD being administered separately via IV in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.

Conditions

This trial is treating patients with Hodgkin's Lymphoma

Cancer

Blood Cancers Haematological

Age

People12+

Phase

II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Seagen Inc.

Scientific Title

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Eligibility

Inclusion

  • Treatment-naïve, 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

  • 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 immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
  • 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
  • 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
  • Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
  • History of a cerebral vascular event within 6 months of first dose of study drug
  • Child-Pugh B or C hepatic impairment
  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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