Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
Condition: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
MeSH terms: Lymphoma
Intervention: Rituximab and Lenalidomide
Intervention description: Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MALT Lymphoma; Lenalidomide; Rituximab; AGMT

Summary:

      This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus
      Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated
      Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.
    

Eligibility criteria:

        Inclusion Criteria selected:

          -  Histologically verified diagnosis if MALT lymphoma of any localization

          -  Measurable disease upon diagnosis or first or greater relapse after local therapy,
             prior chemotherapy orHP-eradication. In addition, also in patients with gastric
             MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months
             after successfulHP-eradication will be included in the study. Patients with gastric
             MALT lymphoma and no evidence of HP-infection 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

          -  Patient must be able to take aspirin daily as prophylactic anticoagulation (patients
             intolerant to ASA may use warfarin or low molecular weight heparin

        Exclusion Criteria selected:

          -  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 or myocardial infarction within the last 6
             months

          -  Known hypersensitivity to thalidomide or lenalidomide or rituximab