NCT00148018

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

July 10, 2008

Status Verified

September 1, 2006

First QC Date

September 1, 2005

Last Update Submit

July 9, 2008

Conditions

Hodgkin Disease

Keywords

Hodgkin diseaseBortezomibRelapseLymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (complete and partial responses)

Secondary Outcomes (5)

  • Toxicity

  • Event free survival

  • Overall survival

  • Duration of response

  • Treatment administration (dose-intensity, total dose)

Interventions

BortezomibDRUG
DexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17488673DERIVED

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseRecurrenceLymphoma

Interventions

BortezomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Andreas Engert

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 7, 2005

Study Start

March 1, 2005

Last Updated

July 10, 2008

Record last verified: 2006-09

Locations

DE(1)