Multicenter preliminary study to evaluate activity and safety of the combination of drugs ofatumumab and bendamustine in patients with marginal zone B-cell lymphomas

Phase 1

• Conditions: marginal zone B-cell lymphomas (MZL); MedDRA version: 14.1Level: PTClassification code 10029463Term: Nodal marginal zone B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029464Term: Nodal marginal zone B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-003495-36-IT
• Lead Sponsor: SENDO TECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age > 18 2. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and/or monoclonal antibodies) 3. Any stage (Ann Arbor I-IV) 3. Life expectancy of at least 6 months and ECOG performance status 0-1 4. No evidence of histological transformation to diffuse large cells lymphoma 5. Adeguate bone marrow function, renal function or liver function 6. Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment 2. Treatment with anti-CD20 monoclonal antibody or alemtuzumab within 8 weeks prior to the enrollment 3. Treatment with corticosteroids during the last 4 weeks 4.Other past or current malignancy 5. Previous organ transplantation 6.Clinically significant cardiac or pulmonary disease 7.History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequele 8. Concomitant infectious diseases, HIV positive, Hepatitis B or C positive.

Study & Design

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