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

Phase 2

Not yet recruiting

• Conditions: Hodgkin Lymphoma (Category)
• Interventions: Drug: BrECADD

• Registration Number: NCT06919679
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-08
• Primary Completion: 2028-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	BrECADD	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	PFS at 1 year