HD17 for Intermediate Stage Hodgkin Lymphoma

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01356680
• Collaborator: (none)
• Enrollment: 1,100
• Location: 1
• Arms: 2
• Actual Duration (Months): 98.3
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

• Study Type: Interventional
• Actual Enrollment: 1100 participants
• 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
• Actual Study Start Date: Jan 13, 2012
• Actual Primary Completion Date: Mar 21, 2020
• Actual Study Completion Date: Mar 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [3 years]

Secondary Outcome Measures

1. Overall Survival [3 years]

2. CR rate [6 months]

   Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Homepage GHSG

Publications

None provided.

• Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT01356680
• Other Study ID Numbers: HD17
• First Posted: May 19, 2011
• Last Update Posted: Apr 6, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Prof. Dr. Andreas Engert, Prof., University of Cologne: Hodgkin Lymphoma; intermediate stage; PET
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Prednisone; Cyclophosphamide; Dacarbazine; Etoposide; Vincristine; Doxorubicin; Liposomal doxorubicin; Bleomycin; Vinblastine; Procarbazine

Study Results

No Results Posted as of Apr 6, 2020