BASTION – Phase II Trial of BrECADD in HIV-Positive Patients with Advanced-Stage Classic Hodgkin Lymphoma

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521749-26-00

Enrollment

Registered

2026-09-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Stage Classic Hodgkin Lymphoma

Brief summary

TRMB rate, defined as the rate of patients having any of the following adverse events (AEs) during treatment with BrECADD including a period of 30 days after the last chemotherapy dose:, Acute non-hematological organ toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4, Acute hematological toxicity of grade 4 anemia, Grade 4 infection

Detailed description

Adverse events, Complete remission (CR) rate after 2 cycles and after completion of chemotherapy, respectively, Proportion of patients receiving 4 cycles BrECADD, Progression-free survival (PFS) and overall survival (OS) after 1 and 2 years, Cumulative incidence of second primary malignancies after 1 and 2 years, Patient-reported outcomes (PRO-CTCAE, quality of life; in patients providing separate informed consent), Therapy adherence, Dose reductions, CD4 lymphocyte counts during therapy, Frequency and reasons of drop-outs

Interventions

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGDACARBAZINE CITRATE

DRUGETOPOSIDE

DRUGDEXAMETHASONE

DRUGADCETRIS 50 mg powder for concentrate for solution for infusion.

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
TRMB rate, defined as the rate of patients having any of the following adverse events (AEs) during treatment with BrECADD including a period of 30 days after the last chemotherapy dose:, Acute non-hematological organ toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4, Acute hematological toxicity of grade 4 anemia, Grade 4 infection	—

Secondary

Measure	Time frame
Adverse events, Complete remission (CR) rate after 2 cycles and after completion of chemotherapy, respectively, Proportion of patients receiving 4 cycles BrECADD, Progression-free survival (PFS) and overall survival (OS) after 1 and 2 years, Cumulative incidence of second primary malignancies after 1 and 2 years, Patient-reported outcomes (PRO-CTCAE, quality of life; in patients providing separate informed consent), Therapy adherence, Dose reductions, CD4 lymphocyte counts during therapy, Frequency and reasons of drop-outs	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 18, 2026