VELCADE in MALT Lymphoma Pretreated With Prior Systemic Therapy

• Sponsor: International Extranodal Lymphoma Study Group (IELSG) (Other)
• Overall Status: Completed
• CT.gov ID: NCT00210327
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Mucosa-Associated Lymphoid Tissue	Drug: Bortezomib (drug)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-cell Lymphoma of MALT-type Pretreated With Prior Systemic Therapy Regimen (X05142)
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Safety, as acute and long-term toxicity []

2. Response duration (RD) (time to relapse or progression) in responders []

3. Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. histologically proven d MALT lymphoma at any extranodal site

2. any stage (Ann Arbor I-IV)

3. relapsed or refractory disease pretreated with prior chemotherapy regimens +/- anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of therapy)

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:

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

11. clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication

12. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks

13. 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

14. 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

15. no evidence of active opportunistic infections

16. no known HIV infection

17. no active HBV and/or HCV infection

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

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

20. 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 within 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona		Switzerland	6500

Sponsors and Collaborators

• International Extranodal Lymphoma Study Group (IELSG)

Investigators

• Study Chair: Franco Cavalli, MD, International Extranodal Lymphoma Study Group

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about this study

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00210327
• Other Study ID Numbers: IELSG25A
• First Posted: Sep 21, 2005
• Last Update Posted: Jul 22, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone; Bortezomib

Study Results

No Results Posted as of Jul 22, 2009