HD21 for Advanced Stages

Classical Hodgkin Lymphoma Clinical Trial

Official title:

HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02661503
• Other study ID #: Uni-Koeln-1762
• Secondary ID: 2014-005130-55
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: September 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• Bleomycin

• Etoposide

• Doxorubicin

• Cyclophosphamide

• Vincristine

• Procarbazine

• Prednisone

• Brentuximab Vedotin

• Dacarbazine

• Dexamethasone

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		5 years
Primary	Treatment Related Morbidity		during 6 cycles of chemotherapy (21-day cycles)