Lymphoma of the Mucosa-Associated Lymphoid Tissue (MALT) MedDRA version: 14.1 Level: LLT Classification code 10060707 Term: MALT lymphoma System Organ Class: 100000004864
Conditions
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, all of the following inclusion criteria must be fulfilled: •Patient understands and voluntarily signs the informed consent prior to any study related assessments/procedures •Male or female = 18 years of age •Histologically verified diagnosis of MALT lymphoma of any localization •Measurable 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 with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection (as judged by histology and ultimately serology) may be enrolled immediately) •Ann Arbor Stage I-IV •In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial. •ECOG performance status of 0,1 or 2 •Age > 18 years •Life expectancy of at least 3 months •Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA (may use warfarin or low molecular weight heparin) •Hematological test results within these ranges: Absolute neutrophil count equal/higher than 1000/µl Platelet count egaul/higher 60 x 109/L •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 •Female subjects of childbearing potential† must: understand the potential teratogenic risk to the unborn child agree to have a medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL (including females of childbearing potential who commit to complete abstinence) details see appendix 6 agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception: •Highly effective methods: Intrauterine device (IUD) Hormonal (birth control pills, injections, implants) Tubal ligation Partner’s vasectomy •Additional effective methods: Male condom Diaphragm Cervical Cap Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia. be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test understand the need and accepts to undergo
Exclusion criteria
Exclusion criteria: No patient may be included into the study if she/he fulfills any of the following 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 with lenalidomide •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 •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 •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 •Uncontrolled diabetes mellitus •Preexisting thromboembolic events at start of study •Known hypersensitivity to thalidomide or lenalidomide or rituximab
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical potential of Rituximab plus Lenalidomide to induce objective/histologic responses in patients with MALT lymphoma;Secondary Objective: To evaluate the safety of Rituximab plus Lenalidomide in this patient population;Primary end point(s): Determination of percentage objective responders in patients with MALT lymphoma treated with the combination therapy of Rituximab and lenalidomide;Timepoint(s) of evaluation of this end point: End of Treatment | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Outcome results
None listed