extranodal marginal zone lymphoma (MALT)
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20
Sponsors
IELSG International Extranodale Lymphoma Study Group; Instituto Oncologico della Svizzera Italiana,
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Adverse events incidence, severity and relationship to study treatment 2. Time from first investigational medicinal product administration to assessment of disease progression or death due to any cause 3. Time from first investigational medicinal product administration to assessment of disease progression or death due to progression 4. Time from first IMP administration to patient’s death;Timepoint(s) of evaluation of this end point: november 2029 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the overall response rate (complete and partial responses) of the combination treatment of clarithromycin and lenalidomide (RevlimidÒ) in patients with MALT lymphoma, refractory or relapsing after radiotherapy and/or chemotherapy and/or immunotherapy.;Secondary Objective: 1. To evaluate the safety profile of the clarithromycin + lenalidomide combination, including any late adverse reactions 2. To assess the progression-free survival after clarithromycin + lenalidomide therapy 3. To assess the time to progression after clarithromycin + lenalidomide therapy 4. To assess the overall survival after clarithromycin+lenalidomide therapy;Primary end point(s): Tumor response assessed according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al) and the GELA (Group d'Etude des Lymphomes de l'Adulte) histological scoring system for post-treatment biopsies of patients with gastric MALT lymphoma. The overall response rate will be represented by the total number of complete and partial responses.;Timepoint(s) of evaluation of this end point: Approximately 40 months from the start of study. | — |
Countries
Austria, Italy, Spain, Switzerland
Outcome results
None listed