Phase II Trial of BrECADD in HIV-Positive Patients With Advanced-Stage Classical Hodgkin Lymphoma

Participants receive chemotherapy with BrECADD in standard doses and cycle length. After the first two cycles, a restaging is performed by contrast-enhanced computed tomography (ceCT) and PET (PET/CT) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of BrECADD in case of a PET-positive or -negative staging result, respectively. A second restaging will be performed after completion of chemotherapy. In patients with PET-positive residual disease, local irradiation followed by another restaging is recommended. ART should be continued during chemotherapy.

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Key information

Conditions

Hodgkin Lymphoma (Category) Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Lentivirus Infections Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically confirmed first diagnosis of cHL
Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
No previous treatment for HL with the exception of steroid prephase
Confirmed HIV infection with CD4 counts ≥ 150/μL at registration or > 250/μL at any time within 8 months prior to HL diagnosis
Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naive
Age: 18-60 years

Exclusion criteria

Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment
Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
Multi-drug resistant HIV infection or concurrent AIDS-defining conditions
Pregnancy or breastfeeding

Treatment and study plan

BrECADD

Drug

Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Primary outcomes

Progression Free Survival

Time frame: PFS at 1 year

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: BASTION

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2030
First posted: Apr 9, 2025
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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