HD21 for Advanced Stages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02661503

Recruitment Status : Active, not recruiting

First Posted : January 22, 2016

Last Update Posted : May 13, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. Peter Borchmann, University of Cologne

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).

Condition or disease	Intervention/treatment	Phase
Classical Hodgkin Lymphoma	Drug: Bleomycin Drug: Etoposide Drug: Doxorubicin Drug: Cyclophosphamide Drug: Vincristine Drug: Procarbazine Drug: Prednisone Drug: Brentuximab Vedotin Drug: Dacarbazine Drug: Dexamethasone	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual 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 :	July 2016
Actual Primary Completion Date :	December 2022
Estimated Study Completion Date :	September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hodgkin Lymphoma

U.S. FDA Resources

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661503

Locations

Layout table for location information

Germany
University Hospital of Cologne
Cologne, Germany

Sponsors and Collaborators

University of Cologne

Investigators

Layout table for investigator information

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

More Information

Layout table for additonal information

Responsible Party:	Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier:	NCT02661503
Other Study ID Numbers:	Uni-Koeln-1762 2014-005130-55 ( EudraCT Number )
First Posted:	January 22, 2016 Key Record Dates
Last Update Posted:	May 13, 2024
Last Verified:	May 2024

Additional relevant MeSH terms:

Layout table for MeSH terms

Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Prednisone Cyclophosphamide Dacarbazine Doxorubicin Etoposide Vincristine	Bleomycin Brentuximab Vedotin Procarbazine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Antiemetics Autonomic Agents

To Top