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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Cologne

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • BrECADD

Treatment groups

35 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators