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Mucosa Associated Lymphoid Tissue (MALT) LymphomaPhase 2NCT03031483

Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma

A Phase 2 study testing clarithromycin and lenalidomide in people with Mucosa Associated Lymphoid Tissue (MALT) Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
clarithromycin and lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
10 sitesin 3 countries
Study dates
3 Apr 2017to 20 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 medication with another person and to return all unused study drug to the investigator
  • Patient must be willing and able to comply with the protocol
  • Patient must be capable of understanding

Who cannot join

  • 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
  • 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
  • HBsAg positivity
  • Evidence of central nervous system involvement
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  • 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 and/or long QT-syndrome
  • HIV seropositivity
  • Presence of active opportunistic infections
  • Pregnancy or lactation
  • Uncontrolled diabetes mellitus
  • Pre-existing thromboembolic conditions at study entry
  • Known hypersensitivity to thalidomide or lenalidomide or macrolide antibiotics
  • Presence of any contraindication reported on the Summary of Product Characteristics (SmPC) of Clarithromycin
  • Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the SmPC of clarithromycin and in the Investigator's Brochure (IB) of lenalidomide

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Italy6 sites

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Papardo

    Messina, 98158

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

  • Ospedale di Circolo e Fondazione Macchi di Varese

    Varese, 21100

  • Azienda Sanitaria ULSS 6 - Ospedale S.Bortolo

    Vicenza, 36100

Other trials in Italy

Spain3 sites

  • Instituto de Enfermedades Hematológicas y Oncológicas

    Barcelona, Barcellona, 08036

  • Institut Català D'Oncologia Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario

    Salamanca, 37007

Other trials in Spain

Austria1 site

  • Medical University of Vienna

    Vienna

Other trials in Austria

About this study

Official title: A Phase II Trial Addressing Feasibility and Activity of Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma

Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy

Being tested
clarithromycin and lenalidomide
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clarithromycin and lenalidomideDrug

    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.

Study groups in NCT03031483
Study groupRoleWhat they receive
Experimental: clarithromycin and lenalidomideExperimentalCLARITHROMYCIN: 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.
Receives: Drug: clarithromycin and lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: During the active treatment period after the 3rd cycles of both drugs administration

Secondary outcomes (1)

  1. 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.

    Measured: During the active treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2017 (estimated)
  2. Study start3 Apr 2017
  3. Primary completion13 Nov 2019
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031483
Sponsor's protocol ID
IELSG40
Status last verified
Jan 2025
First submitted
23 Jan 2017
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pirosa MC, Sassone M, Kiesewetter B, Guillermo AL, Devizzi L, Domenech ED, Tucci A, Mannina D, Merli M, Salar A, Visco C, Esposito F, Bonomini L, Zucca E, Ferreri AJM, Raderer M. IELSG40/CLEO phase II trial of clarithromycin and lenalidomide in relapsed/refractory extranodal marginal zone lymphoma. Haematologica. 2023 Jun 1;108(6):1671-1675. doi: 10.3324/haematol.2022.281963. No abstract available.

    PubMed 36546422

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clarithromycin and lenalidomide in people with Mucosa Associated Lymphoid Tissue (MALT) Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy, Spain, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response assessment (time frame: During the active treatment period after the 3rd cycles of both drugs administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03031483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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