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

University of Cologne

Status and phase: Not yet enrolling; Phase 2

Conditions: Hodgkin Lymphoma (Category)

Treatments: Drug: BrECADD

Study type: Interventional

Funder types: Other

Identifiers

NCT06919679

2025-521749-26-00 (EU Trial (CTIS) Number)

Uni-Koeln-5576

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: BrECADD