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

NCT ID: NCT00148018

Last Updated: 2008-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hodgkin Disease

Keywords

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Hodgkin disease Bortezomib Relapse Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bortezomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role lead

Principal Investigators

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Andreas Engert

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 17488673 (View on PubMed)

Related Links

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

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

Other Identifiers

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X05132

Identifier Type: -

Identifier Source: org_study_id