Phase II Study of VELCADETM in patientswith extranodal marginal zone B-cell lymphoma ofMALT-type pretreated with one prior systemic therapyregimen (X05142)

Phase 1

• Conditions: lymphoma of MALT

• Registration Number: EUCTR2004-004594-29-ES
• Lead Sponsor: International Extranodal Lymphoma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-23
• Study Completion: 2009-10-01
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at
any extranodal site
2. any stage (Ann Arbor I-IV) (see Appendix B)
3. relapsed or refractory disease pretreated with 1 prior chemotherapy regimen +/- anti-CD20
immunotherapy or 1 prior anti-CD20 immunotherapy
4. no evidence of histologic transformation to a high grade lymphoma
5. measurable or evaluable disease
6. age > 18 years
7. full recovery from previous therapy, with life expectancy of at least 6 months
8. ECOG performance status 0-2
9. for primary gastric localized H. pylori-positive disease at diagnosis:
a. persistent disease 1 year after documented H. pylori infection eradication
b. clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication
10. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
2. other investigational drugs with 14 days before enrollment
3. evidence of symptomatic central nervous system (CNS) disease
4. severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within
14 days before enrollment), unless due to lymphoma involvement
5. evidence of grade 2 peripheral neuropathy within 14 days before enrollment
6. known hypersensitivity to bortezomib, boron or mannitol
7. pregnant or lactating status, confirmation that the subject is not pregnant must be
established by a negative serum -human chorionic gonadotropin ( -hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
8. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the antitumor activity, in terms of sum of complete and partial responses (ORR);Secondary Objective: • Safety, as acute and long term toxicity<br>• Response duration (RD) (time to relapse or progression) in responders<br>• Progression-free survival (PFS) (time to disease progression or death from lymphoma): in all<br>patients.;Primary end point(s): the antitumor activity<br>Response duration (RD)<br>Progression-free survival (PFS)