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

NCT06919679 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: Uni-Koeln-55762025-521749-26-00
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hodgkin Lymphoma (Category)

Keywords

advanced stage; HIV positive; Brentuximab Vedotin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  PFS at 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: BrECADD

Interventions

BrECADD DRUG

Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

MeSH Terms

Conditions

Hodgkin Disease; HIV Seropositivity

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 9, 2025

Record last verified: 2025-04