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NCT06919679Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
2 Apr 2025
Start date
Aug 2025
Primary completion date
Jan 2028
Lead sponsor
University of Cologne
NCT number
NCT06919679
EU CT number
2025-521749-26-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 35
  • From Aug 2025 to the primary completion date, Jan 2028
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Multi-drug resistant HIV infection or concurrent AIDS-defining conditions

Other illness

  • Previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment

Lab values

  • Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Other

  • Pregnancy or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
Gesundheit Nord gGmbH Klinikverbund Bremen
Coordinator of this site? Confirm its status
BremenGermanyNot yet recruiting
Universitaetsklinikum Koeln AöR
Coordinator of this site? Confirm its status
CologneGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
Coordinator of this site? Confirm its status
HeidelbergGermanyNot yet recruiting
Rotkreuzklinikum Muenchen gGmbH
Coordinator of this site? Confirm its status
MunichGermanyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.