HD17 for Intermediate Stage Hodgkin Lymphoma
This study is currently recruiting participants.
Verified January 2013 by University of Cologne
Sponsor:
University of Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01356680
First received: May 13, 2011
Last updated: January 25, 2013
Last verified: January 2013
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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:
Drug Information available for:
Cyclophosphamide
Prednisone
Vinblastine sulfate
Procarbazine hydrochloride
Procarbazine
Vinblastine
Vincristine sulfate
Dacarbazine
Bleomycin sulfate
Bleomycin
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
U.S. FDA Resources
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
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, German Hodgkin Study Group |
| ClinicalTrials.gov Identifier: | NCT01356680 History of Changes |
| Other Study ID Numbers: | HD17 |
| Study First Received: | May 13, 2011 |
| Last Updated: | January 25, 2013 |
| 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 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 Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013