NCT00210327

Brief Summary

The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

July 21, 2009

Conditions

Lymphoma, Mucosa-Associated Lymphoid Tissue

Outcome Measures

Primary Outcomes (1)

  • Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses

Secondary Outcomes (3)

  • Safety, as acute and long-term toxicity

  • Response duration (RD) (time to relapse or progression) in responders

  • Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients

Interventions

Bortezomib (drug)DRUG

Eligibility Criteria

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

You may qualify if:

  • histologically proven d MALT lymphoma at any extranodal site
  • any stage (Ann Arbor I-IV)
  • relapsed or refractory disease pretreated with prior chemotherapy regimens +/- anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of therapy)
  • no evidence of histologic transformation to a high grade lymphoma
  • measurable or evaluable disease
  • age \> 18 years
  • full recovery from previous therapy, with life expectancy of at least 6 months
  • ECOG performance status 0-2
  • for primary gastric localized H. pylori-positive disease at diagnosis:
  • persistent disease 1 year after documented H. pylori infection eradication
  • clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication
  • no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
  • no corticosteroids during the last 4 weeks, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms
  • adequate renal function (calculated or measured creatinine clearance \>30 mL/minute), liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal) and bone marrow function
  • no evidence of active opportunistic infections
  • +5 more criteria

You may not qualify if:

  • prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1(CIN1) or localized non-melanomatous skin cancer
  • other investigational drugs within 14 days before enrollment
  • evidence of symptomatic central nervous system (CNS) disease
  • severe impairment of bone marrow function (ANC \<1.0x109/L, PLT \<30x109/L within 14 days before enrollment), unless due to lymphoma involvement
  • evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment
  • known hypersensitivity to bortezomib, boron or mannitol
  • pregnant or lactating status, confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Related Links

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

BortezomibPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Franco Cavalli, MD

    International Extranodal Lymphoma Study Group

    STUDY CHAIR

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 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2005

Primary Completion

November 1, 2008

Study Completion

April 1, 2009

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

CH(1)