HD17 for Intermediate Stage Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
NCT01356680
First received: May 13, 2011
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).


Condition Intervention Phase
Hodgkin Lymphoma
Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • CR rate [ Designated as safety issue: No ]
    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment


Estimated Enrollment: 1100
Study Start Date: December 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
Experimental: Arm B
2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hodgkin Lymphoma
  • CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
  • large mediastinal mass (>1/3 of maximum transverse thorax diameter)
  • extranodal involvement
  • elevated ESR
  • 3 or more involved nodal areas
  • written informed consent

Exclusion Criteria:

  • Leucocytes <3000/µl
  • Platelets < 100000/µl
  • Hodgkin Lymphoma as composite lymphoma
  • Activity Index (WHO) >2
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356680

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

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Andreas Engert, Prof.       a.engert@uni-koeln.de   
Principal Investigator: Andreas Engert, Prof.         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne, German Hodgkin Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01356680     History of Changes
Other Study ID Numbers: HD17
Study First Received: May 13, 2011
Last Updated: June 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Hodgkin Lymphoma
intermediate stage
PET

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Liposomal doxorubicin
Cyclophosphamide
Dacarbazine
Etoposide
Prednisone
Procarbazine
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 28, 2014