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

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 3, 2017

Primary Completion Date

November 13, 2019

Study Completion Date

December 20, 2024

Conditions
Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
Interventions
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."

Trial Locations (10)

20132

IRCCS Ospedale San Raffaele, Milan

20133

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan

21100

Ospedale di Circolo e Fondazione Macchi di Varese, Varese

25123

A.O. Spedali Civili di Brescia, Brescia

36100

Azienda Sanitaria ULSS 6 - Ospedale S.Bortolo, Vicenza

37007

Hospital Universitario, Salamanca

98158

Azienda Ospedaliera Papardo, Messina

Unknown

Medical University of Vienna, Vienna

08036

Instituto de Enfermedades Hematológicas y Oncológicas, Barcelona

08908

Institut Català D'Oncologia Hospital Duran I Reynals, L'Hospitalet de Llobregat

All Listed Sponsors
lead

International Extranodal Lymphoma Study Group (IELSG)

OTHER

NCT03031483 - Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma | Biotech Hunter | Biotech Hunter