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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BrECADD

    Drug

    Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival

Time frame
PFS at 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: