A phase II trial of long-term intravenous treatment with bi-weekly Azithromycin in patients with gastric lymphoma of the mucosa associated lymphoid tissue (MALT-lymphoma)
- Conditions
- gastric MALT LymphomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003152-33-AT
- Lead Sponsor
- Med. Univ. Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 46
•Histologically confirmed gastric MALT lymphoma with measurable disease (stage I – IV)
•• Localized disease: First or greater relapse after surgery, radiation, chemotherapy or HP-eradication (patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication in case of HP-positive gastric lymphoma) or refractoriness/persistence to the said measures.
•HP-negative patients or patients initially diagnosed with disseminated diserase are directly eligible and no initial attempt with antibiotics is considered in daily practice, as efficacy is low.
•Age = 18 years
•Life expectancy of at least 3 months
•Able to tolerate therapy, and have adequate hematological, renal and liver function:
- red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands) >1.0 x 109/L; platelets >50 x 109/L
- serum-creatinine < 2.0 times upper normal limit
- total bilirubin < 1.5 times upper normal limit (unless due to lymphoma involvement of liver or a known history of Gilbert’s disease); ALT < 2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase < 2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
• ECOG-PS 1 or 2
•Capability of understanding the purpose of the study and have given written informed consent.
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 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
•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 study treatment
•History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
•Major surgery, other than diagnostic surgery, within the last 4 weeks
•Evidence of CNS 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
•Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to study enrollment, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450 ms).
•Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment
•Patients with active opportunistic infections
•Known HIV infection
•Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used
•Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
•Male subjects unable or unwilling to use adequate contraception methods.
•Concurrent medication with ergotamine, theophylline or digitalis.
•Patients who are hypersensitive to IMP (Azithromycin) or other Macrolide antibiotics.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: after 3 cycles and after 6 cycles;Main Objective: To evaluate the capacity of intravenous, bi-weekly long-term Azithromycin treatment to induce objective responses in patients with gastric MALT lymphoma, either untreated or at relapse after surgery, radiation and chemotherapy. ;Secondary Objective: To evaluate the safety of intravenous, bi- weekly long-term Azithromycin monotherapy in this patient population.;Primary end point(s): Primary endpoint: rate of objective responses (as judged by best response during the study period)<br>? Clinical response measured according to standard criteria (RECIST 1.1, GELA<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety and tolerance of treatment in terms of hematologic and non-hematologic side effects as assessed by the investigators. Adverse events will also be summarized using frequency counts and percentages.;Timepoint(s) of evaluation of this end point: after 3 cycles and after 6 cycles