Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refra… (NCT03031483) | Clinical Trial Compass
CompletedPhase 2
Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma
Austria, Italy44 participantsStarted 2017-04-03
Plain-language summary
Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: ANC (absolute neutrophil count \[segmented + bands\]) ≥1.0 x 109/L, platelet count ≥ 75 x 109/L , haemoglobin ≥8 g/dL.
* Adequate cardiac, renal and liver function tests (LVEF \> 40%, 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 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 m…
What they're measuring
1
Tumor response assessment
Timeframe: During the active treatment period after the 3rd cycles of both drugs administration
Trial details
NCT IDNCT03031483
SponsorInternational Extranodal Lymphoma Study Group (IELSG)