Study of Bortezomib (Velcade) in Combination With Dexamet... | NCT00148018

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

NCT00148018

Sponsor

University of Cologne

Status

Terminated

Last Update Posted

Jul 10, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Hodgkin Disease

Interventions

Bortezomib
Dexamethasone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2008

Last Update Posted Date

Jul 10, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of CologneOTHER

Collaborators

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

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Overall response rate (complete and partial responses)

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Engert	University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne		Cologne	North Rhine-Westphalia	50924	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17488673	Derived	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.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals

Name	Type	Description	Arm Group Labels	Other Names
Bortezomib	Drug
Dexamethasone	Drug

Measure	Description	Time Frame
Toxicity
Event free survival
Overall survival

ID	Term
D006689	Hodgkin Disease
D012008	Recurrence
D008223	Lymphoma

ID	Term
D000069286	Bortezomib
D003907	Dexamethasone