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Spots Global Cancer Trial Database for Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma

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Trial Identification

Brief Title: Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma

Official Title: A Phase II Study of Chlorambucil in Combination With Subcutaneous Rituximab Followed by Maintenance Therapy With Subcutaneous Rituximab in Patients With Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)

Study ID: NCT01808599

Conditions

MALT Lymphoma

Study Description

Brief Summary: Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).

Detailed Description: The study consists in three parts. In Part A (induction phase I) patients will be treated with Chlorambucil 6 mg/m2 daily p.o for 42 consecutive days (weeks 1-6) in combination with intravenous Rituximab 375mg/m2 on day 1 week 1 followed by subcutaneous Rituximab 1400mg on days 8, 15 and 22 (day 1 of weeks 2, 3 and 4). After restaging (CT scan to be performed during weeks 7-8, i.e. between d42 and d55), responding patients (CR, CRu, PR) and those with stable disease will be treated in part B (induction phase II). In part B, starting from d56, (month 3) patients will receive Chlorambucil 6 mg/m2 daily p.o for 14 consecutive days (d1-14) every 28 days for 4 cycles in combination with subcutaneous Rituximab 1400mg on day 1 of each 28-day cycle. After restaging (CT scan to be performed at the end of month 6) responding patients and those with stable disease will be treated in part C. In Part C (maintenance phase) patients will be treated with subcutaneous Rituximab 1400mg every two months for 2 years (in total 12 injections). During maintenance phase, CT scans will be performed every 12 months and patients responding or with stable disease will stay on treatment for a total of two years as above reported.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Créteil Hopital Henri Mondor, Créteil, , France

Dijon CHU Hopital le Bocage, Dijon, , France

Clermont Ferrand CHU Estaing, Estaing, , France

Grenoble CHU Pontchaillou, Grenoble, , France

Lille CHRU Hopital Claude Dieu, Lille, , France

Pierre Bénite CHU Lyon Sud, Lyon, , France

Marseille Paoli Calmettes, Marseille, , France

Montpellier CHU Saint Eloi, Montpellier, , France

Vandoeuvre lès Nancy CHU Brabois, Nancy, , France

Nantes CHU Hotel Dieu, Nantes, , France

Paris Hopital Saint Louis, Paris, , France

Rennes CHU Pontchaillou, Rennes, , France

Rouen Centre Henri Becquerel, Rouen, , France

Tours CHU Bretonneau, Tours, , France

AO SS. Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy

Ancona, Ancona, , Italy

Centro di Riferimento Oncologico di Aviano, Aviano, , Italy

Biella Ospedale degli Infermi, Biella, , Italy

Ematologia e CTMO Ospedale Bolzano, Bolzano, , Italy

Ematologia Ospedale Businco (Cagliari), Cagliari, , Italy

ARNAS Garibaldi Catania, Catania, , Italy

Genova Ematologia I H San Martino, Genova, , Italy

Azienda Sanitaria AUSL6 Livorno, Livorno, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Meldola, , Italy

Istituto Nazionale dei Tumori, Milano, Milano, , Italy

Milano Ospedale Policlinico, Milano, , Italy

Nocera, Nocera Umbra, , Italy

IOV Padova, Padova, , Italy

Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy

UO Ematologia Ravenna, Ravenna, , Italy

Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, , Italy

Ospedale Infermi Ematologia Rimini, Rimini, , Italy

IRCCS/CROB Rionero in Vulture, Rionero in Vulture, , Italy

Istituto Regina Elena, Roma, IFO, Roma, , Italy

SC Oncoematologia Terni, Terni, , Italy

SC Ematologia Torino-Molinette, Torino, , Italy

Torino Università, Ematologia 1, AO Città della Salute e della Scienza, Torino, , Italy

IOSI - Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland

Contact Details

Name: Emanuele Zucca, MD

Affiliation: IOSI Oncology Institute of Southern Switzerland

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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