A study to improve the treatment in the first-line treatment of advanced stage Hodgkin lymphoma

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005130-55-DE

Enrollment

1500

Registered

2016-01-12

Start date

2016-05-18

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Adcetris Product Name: Adcetris Pharmaceutical Form: Lyophilisate for solution for infusion Trade Name: Adrimedac Product Name: Adrimedac Pharmaceutical Form: Lyophilisate for solution fo

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

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
Main Objective: Primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP;Secondary Objective: Tumor response (CR/CRr rate) Overall survival (OS) Infertility rate at 1 year Second malignancies Quality of life (QoL) Frequency of adverse events Therapy adherence Event free survival;Primary end point(s): Randomized main study: • Treatment-related morbidity (TRMB) • Progression-free survival (PFS) Cohort of older patients: • Complete remission (CR) rate after chemotherapy ;Timepoint(s) of evaluation of this end point: Analysis of primary toxicity endpoint (16 months after LPI). Interim analysis of efficacy endpoint (randomized cohort) approximately 36 months of median follow-up. Superiority analysis for efficacy (randomized cohort) approximately 48 months of median follow-up. Final analysis of efficacy endpoint within 6 months after LPLV.	—

Measure

Time frame

Main Objective: Primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP;Secondary Objective: Tumor response (CR/CRr rate) Overall survival (OS) Infertility rate at 1 year Second malignancies Quality of life (QoL) Frequency of adverse events Therapy adherence Event free survival;Primary end point(s): Randomized main study: • Treatment-related morbidity (TRMB) • Progression-free survival (PFS) Cohort of older patients: • Complete remission (CR) rate after chemotherapy ;Timepoint(s) of evaluation of this end point: Analysis of primary toxicity endpoint (16 months after LPI). Interim analysis of efficacy endpoint (randomized cohort) approximately 36 months of median follow-up. Superiority analysis for efficacy (randomized cohort) approximately 48 months of median follow-up. Final analysis of efficacy endpoint within 6 months after LPLV.

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Secondary

Measure	Time frame
Secondary end point(s): Tumor response (CR/CRr rate) Overall survival (OS) Infertility rate at 1 year Second malignancies Quality of life (QoL) Frequency of adverse events Therapy adherence. Event free survival (EFS).;Timepoint(s) of evaluation of this end point: Final analysis of secondary endpoints within 6 months after LPLV.	—

Countries

Austria, Denmark, Germany, Netherlands, Poland, Sweden

Contacts

Public ContactTrial Coordination Center

German Hodgkin Study Group

ghsg@uk-koeln.de004922147888200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026