PHASE II TRIAL OF BORTEZOMIB (VELCADE®) IN PATIENTS WITH ADVANCED OR RELAPSED LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT)

Phase 1

• Conditions: patients with MALT-lymphoma

• Registration Number: EUCTR2005-003077-25-AT
• Lead Sponsor: AKH Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-08
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Histologically verified diagnosis of MALT lymphoma of any localization
• Disseminated disease upon diagnosis or first or greater relapse after local therapy (including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP-eradication. In addition, also patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study.
• Measurable disease
• Ann Arbor Stage I-IV
• ECOG performance status of 0,1 or 2 (see Appendix )
• Age between 19 and 80 years
• Life expectancy of at least 3 months
• Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
• Patient must be willing and able to comply with the protocol for the entire study duration
• Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period
• Patient’s written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

• Lymphoma histology other than MALT lymphoma or MALT lymphoma tranforming to diffuse large cell lymphoma (high grade lymphoma”)
• Use of any investigational agent in the month prior to inclusion
• History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
• Major surgery, other than diagnostic surgery, within the last 4 weeks
• Evidence of CNS involvement
• A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
• Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) <1.0 x 109/L
• Patients with active opportunistic infections
• Pregnancy

Study & Design

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