HD21 for Advanced Stages

May 10, 2024 updated by: Prof. Dr. Peter Borchmann, University of Cologne

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BEACOPP
4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Vincristine
Drug: Bleomycin
Drug: Doxorubicin
Drug: Etoposide
Drug: Procarbazine
Experimental: BRECADD
4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Etoposide
Drug: Brentuximab Vedotin
Drug: Dacarbazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 5 years
5 years
Treatment Related Morbidity
Time Frame: during 6 cycles of chemotherapy (21-day cycles)
during 6 cycles of chemotherapy (21-day cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Peter Borchmann, Prof., University of Cologne, I. Dept. of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimated)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-1762
  • 2014-005130-55 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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