HD21 for Advanced Stages

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ClinicalTrials.gov Identifier: NCT02661503

Recruitment Status : Recruiting

First Posted : January 22, 2016

Last Update Posted : August 8, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. Peter Borchmann, University of Cologne

Tracking Information

First Submitted Date ^ICMJE

January 19, 2016

First Posted Date ^ICMJE

January 22, 2016

Last Update Posted Date

August 8, 2022

Study Start Date ^ICMJE

July 2016

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

HD21 for Advanced Stages

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Classical Hodgkin Lymphoma

Intervention ^ICMJE

Drug: Bleomycin
Drug: Etoposide
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Procarbazine
Drug: Prednisone
Drug: Brentuximab Vedotin
Drug: Dacarbazine
Drug: Dexamethasone

Study Arms ^ICMJE

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.
Interventions:
- 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.
Interventions:
- Drug: Etoposide
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Brentuximab Vedotin
- Drug: Dacarbazine
- Drug: Dexamethasone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

September 2025

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Michael Fuchs

ghsg@uk-koeln.de

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02661503

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Prof. Dr. Peter Borchmann, University of Cologne

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

University of Cologne

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Borchmann, Prof.

University of Cologne, I. Dept. of Medicine

PRS Account

University of Cologne

Verification Date

August 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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