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HD21 for Advanced Stages

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ClinicalTrials.gov Identifier: NCT02661503
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease

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



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]
  2. Treatment Related Morbidity [ Time Frame: during 6 cycles of chemotherapy (21-day cycles) ]


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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

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


Contacts
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Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, Germany
Contact: Peter Borchmann, Prof.         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Peter Borchmann, Prof. University of Cologne, I. Dept. of Medicine

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Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT02661503     History of Changes
Other Study ID Numbers: Uni-Koeln-1762
2014-005130-55 ( EudraCT Number )
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Prednisone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Vincristine
Bleomycin
Procarbazine
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists