HD21 for advanced stages: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD; a randomized phase III trial

HD21 for advanced stages: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD; a randomized phase III trial - HD21 (advanced stage)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50640

Enrollment

100

Registered

2017-03-13

Start date

2018-03-06

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Hodgkin's disease

Interventions

Patients are randomized to receive either 4-6 cycles of escalated BEACOPP regimen (standard group) or 4-6 cycles of BrECADD (experimental group). After the first two cycles, a restaging is performed

Patients with PET-positive residual disease will receive local irradiation, while patients in complete remission do not receive radiotherapy. Amendment March 2020: all patients in the elderly cohor

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically proven classical Hodgkin lymphoma - First diagnosis, no previous treatment - 18 to 60 years of age; cohort elderly: 61-75 years - Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion criteria

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 - Concurrent disease which precludes protocol treatment - Pregnancy, lactation - Non-Compliance

Design outcomes

Primary

Measure	Time frame
- Progression Free Survival (PFS). - the rate of serious treatment- related toxicities during primary treatment. New cohort for elderly 61-75 years: - Complete response (CR) rate after chemotherapy	—

Secondary

Measure	Time frame
- CR rate - Overall survival - Infertility rate at 1 year (determined by hormone levels) - second malignancies - number of serious adverse events within 30 days after end of treatment. - therapy adherence - quality of life before, during and after therapy Cohort elderly patients 61-75 years: - Treatment related morbidity - PFS and OS - time to progression and HL-specific survival	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)