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Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

Primary Purpose

Hodgkin Disease

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Bortezomib

Dexamethasone

About this trial

This is an interventional treatment trial for Hodgkin Disease focused on measuring Hodgkin disease, Bortezomib, Relapse, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hodgkin's lymphoma Second or higher relapse (first relapse if high-dose chemotherapy not possible) Age >/= 18 years No major organ dysfunction or intercurrent disorder Written informed consent Exclusion Criteria: Pregnant or nursing

Sites / Locations

University of Cologne

Outcomes

Primary Outcome Measures

Overall response rate (complete and partial responses)

Secondary Outcome Measures

Toxicity

Event free survival

Overall survival

Duration of response

Treatment administration (dose-intensity, total dose)

Full Information

NCT ID

NCT00148018

First Posted

September 1, 2005

Last Updated

July 9, 2008

Sponsor

University of Cologne

Collaborators

German Hodgkin's Lymphoma Study Group, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00148018

Brief Title

Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

Official Title

A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

Collaborators

German Hodgkin's Lymphoma Study Group, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

5. Study Description

Brief Summary

The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Detailed Description

The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Disease

Keywords

Hodgkin disease, Bortezomib, Relapse, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Primary Outcome Measure Information:

Title

Overall response rate (complete and partial responses)

Secondary Outcome Measure Information:

Title

Toxicity

Title

Event free survival

Title

Overall survival

Title

Duration of response

Title

Treatment administration (dose-intensity, total dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Engert

Organizational Affiliation

University of Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cologne

City

Cologne

State/Province

NRW

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

17488673

Citation

Trelle S, Sezer O, Naumann R, Rummel M, Keller U, Engert A, Borchmann P. Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018). Haematologica. 2007 Apr;92(4):568-9. doi: 10.3324/haematol.10797.

Results Reference

derived

Links:

URL

http://www.lymphome.de/en/

Description

Description of study in German (Website of the Competence Network Malignant Lymphoma)

Learn more about this trial

Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

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