A Phase 2 interventional study of clarithromycin and lenalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma, sponsored by International Extranodal Lymphoma Study Group (IELSG). Completed at 10 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by International Extranodal Lymphoma Study Group (IELSG) · Phase 2, Interventional, and Treatment
Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy
428 studies on the registry are indexed under Lymphoma, B-Cell, Marginal Zone; 108 are open to participants now.
This study's enrollment of 44 is close to the median of 43 across 373 interventional studies indexed under Lymphoma, B-Cell, Marginal Zone.
Browse Lymphoma, B-Cell, Marginal Zone studies →International Extranodal Lymphoma Study Group (IELSG) is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
CLARITHROMYCIN: daily orally administration in cycles of 28 days; 500mg film-coated tablets LENALIDOMIDE: every cycle of treatment lasts 28 days; daily orally administration is of 21 consecutive days with a week of rest. 20mg capsule hard. The maximum treatment duration is 12 months.
Drug: clarithromycin and lenalidomide
Drug pages: Clarithromycin · Lenalidomide
Each treatment course will consist of: Oral Lenalidomide (Revlimid) once daily for 21 days at a dose 20 mg; in case of drug-related adverse events the dose can be reduced to 15 and 10 mg/day; Oral Clarithromycin 500 mg twice daily for 28 days. Courses will be repeated every 28 days. After the first 3 courses patients with stable disease or better response will be given another three courses. Patients with complete remission or disease progression after 6 courses will be taken off study, while patients with partial response or stable disease will receive 3 further courses of treatment. Again, patients with complete response or disease progression will stop therapy, while patients with partial response/stable disease will receive 3 further courses up to a maximum of 12 courses in total.
Tumor response assessment
The primary outcome measure is tumour response assessed according to the Revised Response Criteria for Malignant Lymphoma, either clinically (including appropriate imaging procedures) or endoscopically and histologically (in patients affected by gastric lymphoma, according to the GELA scoring system).
Time frame: During the active treatment period after the 3rd cycles of both drugs administration
Adverse Events assessments
1. Treatment-emergent adverse events (AEs) incidence, severity and relationship to study treatment. 2. Time from first IMP administration to assessment of disease progression or death due to any cause, whichever occurs earlier.
Time frame: During the active treatment period
Ran from Apr 2017 to primary completion in Nov 2019, 31 months.
Of 70 non-industry phase 2 interventional studies under Lymphoma, B-Cell, Marginal Zone, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 110. This study's 31 months is below that.
Counting every sponsor, half of 86 studies reached it within 67 months; a quarter within 37 and three quarters within 101.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Clarithromycin · Lenalidomide
Lymphoma, B-Cell, Marginal Zone →
International Extranodal Lymphoma Study Group (IELSG)