A study with the aim to evaluate the antitumor activity of a new association of oral drugs, lenalidomide and clarithromycin in patients with lymphoma (MALT), when standard treatment with radiation therapy, chemotherapy and / or immunotherapy have shown a lack of efficacy.

Phase 1

• Conditions: Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy.; MedDRA version: 21.0Level: PTClassification code 10015823Term: Extranodal marginal zone B-cell lymphoma (MALT type) recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10015824Term: Extranodal marginal zone B-cell lymphoma (MALT type) refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-003168-35-IT
• Lead Sponsor: IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-20
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

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
- 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)
- 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
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

- Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high gradelymphoma”) - component
- 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
- 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
- Presence of active opportunistic infections
- Pregnancy or lactation
- Uncontrolled diabetes mellitus
- Pre-existing thromboembolic conditions at study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified