HD21 for Advanced Stages

  • STATUS
    Recruiting
  • End date
    Sep 21, 2025
  • participants needed
    1500
  • sponsor
    University of Cologne
Updated on 21 June 2021
cyclophosphamide
lymphoma
vincristine
prednisone
etoposide
doxorubicin
bleomycin
dacarbazine
brentuximab

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).

Details
Condition Classical Hodgkin Lymphoma
Treatment cyclophosphamide, etoposide, prednisone, Dexamethasone, Bleomycin, vincristine, doxorubicin, dacarbazine, procarbazine, brentuximab vedotin
Clinical Study IdentifierNCT02661503
SponsorUniversity of Cologne
Last Modified on21 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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