Hodgkin Lymphoma (Category)
Conditions
Keywords
advanced stage, HIV positive, Brentuximab Vedotin
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.
Interventions
DRUGBrECADD
Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone
Sponsors
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | PFS at 1 year |
Outcome results
None listed