Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031483
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE April 3, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Tumor response assessment [ Time Frame: During the active treatment period after the 3rd cycles of both drugs administration ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03031483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Adverse Events assessments [ Time Frame: During the active treatment period ]
  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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma
Official Title  ICMJE 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
Brief Summary Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
Intervention  ICMJE Drug: clarithromycin and 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.

Study Arms  ICMJE Experimental: Experimental: clarithromycin and lenalidomide
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.
Intervention: Drug: clarithromycin and lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2030
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrès Ferreri, MD +41 02 2643 ext 7649 ferreri.andres@hsr.it
Contact: Markus Raderer, MD markus.raderer@meduniwien.ac.at
Listed Location Countries  ICMJE Austria,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031483
Other Study ID Numbers  ICMJE IELSG40
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Extranodal Lymphoma Study Group (IELSG)
Study Sponsor  ICMJE International Extranodal Lymphoma Study Group (IELSG)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emanuele Zucca, Prof International Extranodal Lymphoma Study Group
PRS Account International Extranodal Lymphoma Study Group (IELSG)
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP