HD10 for Early Stages
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ClinicalTrials.gov Identifier: NCT00265018 |
Recruitment Status :
Completed
First Posted : December 13, 2005
Last Update Posted : July 29, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin´s Lymphoma | Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 30 Gy IF-RT Radiation: 20 Gy IF-RT | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1370 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 1998 |
Actual Primary Completion Date : | January 2003 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm A |
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 30 Gy IF-RT |
Experimental: Arm B |
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 20 Gy IF-RT |
Experimental: Arm C |
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 30 Gy IF-RT |
Experimental: Arm D |
Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Radiation: 20 Gy IF-RT |
- Progression free survival (PFS) [ Time Frame: 5 years ]

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Ages Eligible for Study: | 16 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hodgkin´s lymphoma (histologically proven)
-
CS (PS) IA, IB, IIA,IIB without any of the following risk factors:
- bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
- extranodal involvement
- ESR > 50 (A), > 30 (B-symptoms)
- 3 or more lymph node areas involved
- written informaed consent
Exclusion Criteria:
- Leukocytes <3000/microl
- Platelets <100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) < grade 2

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): NCT00265018
Principal Investigator: | Volker Diehl, Prof. | University of Cologne |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00265018 |
Other Study ID Numbers: |
HD10 |
First Posted: | December 13, 2005 Key Record Dates |
Last Update Posted: | July 29, 2011 |
Last Verified: | July 2011 |
Hodgkin´s lymphoma early stages |
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Doxorubicin Liposomal doxorubicin Bleomycin |
Vinblastine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |