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

Phase 2Not Yet RecruitingNCT06919679

University of Cologne35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma (Category)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes