HD21 for Advanced Stages

Rekrutierend

Studienbeginn:
Juli 2016

Letztes Update:
08.08.2022

Wirkstoff:
Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Brentuximab vedotin, Dacarbazine, Dexamethasone

Indikation (Clinical Trials):
Lymphoma, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

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

Kontakt

Michael Fuchs
Kontakt:
E-Mail: ghsg@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital of Cologne
Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Peter Borchmann, Prof.» Ansprechpartner anzeigen

Studien-Informationen

Brief 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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression Free Survival (Time Frame - 5 years)

2. Treatment Related Morbidity (Time Frame - during 6 cycles of chemotherapy (21-day cycles))

Studien-Arme

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.
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.

Geprüfte Regime

Bleomycin
Etoposide
Doxorubicin
Cyclophosphamide
Vincristine
Procarbazine
Prednisone
Brentuximab Vedotin
Dacarbazine
Dexamethasone

Quelle: ClinicalTrials.gov