HD21 for Advanced Stages

Phase 3Active Not RecruitingNCT02661503

University of Cologne1,500 enrolled

Overview

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective). If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Classical Hodgkin Lymphoma

Interventions

BleomycinDRUG

EtoposideDRUG

DoxorubicinDRUG

CyclophosphamideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven classical Hodgkin lymphoma * First diagnosis, no previous treatment, 18 to 60 years of age * Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV Exclusion Criteria: * Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma * Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1) * Prior chemotherapy or radiotherapy

Locations (1)

University Hospital of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: 5 years

Treatment Related Morbidity

Time frame: during 6 cycles of chemotherapy (21-day cycles)

Data from ClinicalTrials.gov

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