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Not yet recruiting NCT06919679

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

Phase II Interventional Hodgkin Lymphoma (Category)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BrECADD.
Who it may be relevant to
Registry conditions: Hodgkin Lymphoma (Category). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug BrECADD
    Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Primary outcome measures

  • Progression Free Survival [Time frame: PFS at 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06919679 · Uni-Koeln-5576 · 2025-521749-26-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗