A phase II trial clarithromycin + lenalidomide combination:for patients with relapsed/refractory extranodal marginal zone lymphoma

Phase 1

• Conditions: extranodal marginal zone lymphoma (MALT); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003168-35-AT
• Lead Sponsor: IELSG International Extranodale Lymphoma Study Group; Instituto Oncologico della Svizzera Italiana,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-04
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

· Histologically verified diagnosis of MALT lymphoma arising at any extranodal site
· Disease refractory to or in first or greater relapse after prior radiotherapy and/or chemotherapy and/or immunotherapy
· Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
· Ann Arbor Stage I-IV
· ECOG performance status of 0, 1 or 2
· Age = 18 years
· Life expectancy of at least 3 months
· Adequate haematological status
· Adequate cardiac, renal and liver function tests
· Patient must be willing and able to comply with the protocol for the entire study duration
· Female patients of childbearing potential must agree to use, and be able to comply with, effective contraception and agree to have medically supervised pregnancy tests prior to starting the study treatment and during therapy
· Male patients must agree to always use a condom during any sexual contact with females of reproductive potential and agree to not donate
sperm while taking lenalidomide
· Patient must agree to abstain from donating blood while taking study drug therapy
· Patient must agree not to share study medication with another person and to return all unused study drug to the investigator
· Patient must be willing and able to comply with the protocol
· Patient must be capable of understanding the purpose of the study and have given 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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

· Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high grade lymphoma”) -
component
· Use of any investigational agent within 28 days prior to initiation of treatment
· History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix within
the last 5 years unless in complete remission since at least 3 years
· Dependency on red blood cell and/or platelet transfusions
· Evidence of central nervous system 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
· Severe peripheral polyneuropathy
· 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 and/or long QT-syndrome
· HIV seropositivity
· Presence of active opportunistic infections
· Pregnancy or lactation
· Uncontrolled diabetes mellitus
· Pre-existing thromboembolic conditions at study entry
· Known hypersensitivity to thalidomide or lenalidomide or macrolide

Study & Design

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