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Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-Cell Lymphoma of MALT-Type Pretreated With More Than One Prior Systemic Therapy Regimen (X05142)

Phase 2
18 Years
Not Enrolling
Lymphoma, Mucosa-Associated Lymphoid Tissue

Thank you

Trial Information

Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-Cell Lymphoma of MALT-Type Pretreated With More Than One Prior Systemic Therapy Regimen (X05142)

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

During treatment and one month after treatment completion

Safety Issue:


Principal Investigator

Franco Cavalli

Investigator Role:

Study Chair

Investigator Affiliation:

International Extranodal Lymphoma Study Group


Switzerland: Swissmedic

Study ID:




Start Date:

July 2005

Completion Date:

November 2007

Related Keywords:

  • Lymphoma, Mucosa-Associated Lymphoid Tissue
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone