NCT00261612

Brief Summary

Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel drugs have shown promising results in early clinical evaluations. In the current trial, we investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal antibody), and dexamethasone in patients with MCL, who have already been pretreated by standard chemotherapy and show again signs of disease progression. The study objectives include remission rates, safety of this drug combination, and survival time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 18, 2006

Status Verified

October 1, 2006

First QC Date

December 1, 2005

Last Update Submit

October 17, 2006

Conditions

Lymphoma, Mantle-Cell

Keywords

relapsed or chemotherapy-refractory disease

Outcome Measures

Primary Outcomes (1)

  • response rate

Secondary Outcomes (3)

  • safety

  • progression free survival

  • overall survival

Interventions

bortezomibDRUG
rituximabDRUG
dexamethasoneDRUG
treatment protocolPROCEDURE

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mantle cell lymphoma at stage II - IV, previously treated with at least one line of prior therapy (CHOP or CHOP-like), measurable disease, age 19 - 75 years, adequate cardiac, liver and renal function tests, patient's written informed consent

You may not qualify if:

  • second malignancy, evidence for CNS involvement, clinically significant peripheral neuropathy (grade II or higher), HIV positivity, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology

Vienna, Austria

Location

Related Publications (3)

  • Drach J, Seidl S, Kaufmann H. Treatment of mantle cell lymphoma: targeting the microenvironment. Expert Rev Anticancer Ther. 2005 Jun;5(3):477-85. doi: 10.1586/14737140.5.3.477.

    PMID: 16001955BACKGROUND

  • Kaufmann H, Raderer M, Wohrer S, Puspok A, Bankier A, Zielinski C, Chott A, Drach J. Antitumor activity of rituximab plus thalidomide in patients with relapsed/refractory mantle cell lymphoma. Blood. 2004 Oct 15;104(8):2269-71. doi: 10.1182/blood-2004-03-1091. Epub 2004 May 27.

    PMID: 15166030BACKGROUND

  • Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. doi: 10.3324/haematol.2011.041392. Epub 2011 Apr 12.

    PMID: 21486866DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-CellRecurrence

Interventions

BortezomibRituximabDexamethasoneClinical Protocols

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms 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 CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Johannes Drach, MD

    Medical University Vienna

    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

December 1, 2005

First Posted

December 5, 2005

Study Start

January 1, 2005

Study Completion

January 1, 2007

Last Updated

October 18, 2006

Record last verified: 2006-10

Locations

AU(1)