Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT03031483|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2017
Last Update Posted : December 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mucosa Associated Lymphoid Tissue (MALT) Lymphoma||Drug: clarithromycin and lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2030|
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.
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.
- 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).
- Adverse Events assessments [ Time Frame: During the active treatment period ]
- Treatment-emergent adverse events (AEs) incidence, severity and relationship to study treatment.
- Time from first IMP administration to assessment of disease progression or death due to any cause, whichever occurs earlier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031483
|Study Director:||Emanuele Zucca, Prof||International Extranodal Lymphoma Study Group|