Overview

VELCADE in MALT Lymphoma Pretreated With More Than One Prior Systemic Therapy

Status:
Terminated
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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 more than one prior systemic therapy regimen
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Treatments:
Bortezomib
Criteria
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)

3. relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or
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:

1. persistent disease 1 year after documented H. pylori infection eradication

2. 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

11. 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

12. 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

13. no evidence of active opportunistic infections

14. no known HIV infection

15. no active HBV and/or HCV infection

16. no serious medical illness likely to interfere with participation in this clinical
study

17. voluntary written informed consent before performance of any study-related procedure

18. female subject is either post-menopausal or surgically sterilized or willing to use an
acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study. Male subject agrees to use an acceptable method for
contraception for the duration of the study

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 beta-human chorionic gonadotropin (beta-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