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

NCT ID: NCT06919679

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2030-01-31

Brief Summary

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.

Conditions

Hodgkin Lymphoma (Category)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

BrECADD

Intervention Type: DRUG

Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Interventions

BrECADD

Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Peter Borchmann

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025-521749-26-00

Identifier Type: CTIS

Identifier Source: secondary_id

Uni-Koeln-5576

Identifier Type: -

Identifier Source: org_study_id