A PHASE II TRIAL OF LONG-TERM TREATMENT WITH AZITHROMYCIN IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT) LYMPHOMA

Phase 1

• Conditions: MALT Lymphoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001521-13-AT
• Lead Sponsor: Med. Univ. Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-19
• Study Completion: 2019-06-11
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- Histologically confirmed MALT lymphoma with measurable disease (stage I – IV)
- Gastric lymphoma: 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 are directly eligible and no initial attempt with antibiotics is considered in daily practice, as efficacy is low.
- Extragastric lymphoma: Measurable disease stage I - IV
- Age > 18 years
- Life expectancy of at least 3 months
- Patient must be able to tolerate therapy, and have adequate cardiac, renal and liver function
- ECOG-PS status of ? 3
- Patient must be capable 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

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 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 randomization, 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
- Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands) <1.0 x 109/L; platelets <50 x 109/L
- Inadequate kidney function: serum-creatinine >2.0 times upper normal limit
- Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due to DLBCL 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)
- Patients with active opportunistic infections
- Known HIV positivity
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days of 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 is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
- Concurrent medication with ergotamine, theophylline or digitalis.
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- 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
Main Objective: To evaluate the capacity of azithromycin to induce objective responses in patients with MALT lymphoma, either untreated or at relapse after surgery, radiation and chemotherapy. In addition, also patients with disease refractory to HP-eradication after a minimum follow-up of 12 months will be enrolled. Patients with gastric MALT lymphoma and no evidence of HP-infection (as judged by histology and ultimately serology) may be enrolled immediately.;Secondary Objective: To evaluate the safety of once weekly long-term azithromycin therapy in this patient population.;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na