HD21 for Advanced Stages

Sponsor
University of Cologne (Other)
Overall Status
Recruiting
CT.gov ID
NCT02661503
Collaborator
(none)
1,500
1
2
110
13.6

Study Details

Study Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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: Bleomycin

Drug: Etoposide

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Procarbazine

Drug: Prednisone

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: Etoposide

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Brentuximab Vedotin

Drug: Dacarbazine

Drug: Dexamethasone

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival [5 years]

  2. Treatment Related Morbidity [during 6 cycles of chemotherapy (21-day cycles)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Cologne Cologne Germany

Sponsors and Collaborators

  • University of Cologne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier:
NCT02661503
Other Study ID Numbers:
  • Uni-Koeln-1762
  • 2014-005130-55
First Posted:
Jan 22, 2016
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 8, 2022