HD21 for Advanced Stages

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cologne
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Peter Borchmann, Prof. – University of Cologne
  • Overall Official(s)
    • Peter Borchmann, Prof., Principal Investigator, University of Cologne, I. Dept. of Medicine
  • Overall Contact(s)
    • Michael Fuchs, ghsg@uk-koeln.de

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