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HD17 for Intermediate Stage Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356680
First Posted: May 19, 2011
Last Update Posted: May 3, 2017
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.
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
  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
Intervention Model: Parallel Assignment
Masking: None (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 Prof. Dr. Andreas Engert, University of Cologne:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ]
  • CR rate [ Time Frame: 6 months ]
    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment


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

Information from the National Library of Medicine

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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:

  • 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
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): NCT01356680


Locations
Germany
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof. University of Cologne, German Hodgkin Study Group
  More Information

Additional Information:
Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01356680     History of Changes
Other Study ID Numbers: HD17
First Submitted: May 13, 2011
First Posted: May 19, 2011
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:
Hodgkin Lymphoma
intermediate stage
PET

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Prednisone
Etoposide
Vincristine
Doxorubicin
Bleomycin
Vinblastine
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists