- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808599
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Créteil, France
- Créteil Hopital Henri Mondor
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Dijon, France
- Dijon CHU Hopital le Bocage
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Estaing, France
- Clermont Ferrand CHU Estaing
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Grenoble, France
- Grenoble CHU Pontchaillou
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Lille, France
- Lille CHRU Hopital Claude Dieu
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Lyon, France
- Pierre Bénite CHU Lyon Sud
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Marseille, France
- Marseille Paoli Calmettes
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Montpellier, France
- Montpellier CHU Saint Eloi
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Nancy, France
- Vandoeuvre lès Nancy CHU Brabois
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Nantes, France
- Nantes CHU Hotel Dieu
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Paris, France
- Paris Hopital Saint Louis
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Rennes, France
- Rennes CHU Pontchaillou
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Rouen, France
- Rouen Centre Henri Becquerel
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Tours, France
- Tours CHU Bretonneau
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Alessandria, Italy
- AO SS. Antonio e Biagio e Cesare Arrigo
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Ancona, Italy
- Ancona
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Aviano, Italy
- Centro di Riferimento Oncologico di Aviano
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Biella, Italy
- Biella Ospedale degli Infermi
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Bolzano, Italy
- Ematologia e CTMO Ospedale Bolzano
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Cagliari, Italy
- Ematologia Ospedale Businco (Cagliari)
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Catania, Italy
- ARNAS Garibaldi Catania
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Genova, Italy
- Genova Ematologia I H San Martino
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Livorno, Italy
- Azienda Sanitaria AUSL6 Livorno
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Meldola, Italy
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola
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Milano, Italy
- Istituto Nazionale dei Tumori, Milano
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Milano, Italy
- Milano Ospedale Policlinico
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Nocera Umbra, Italy
- Nocera
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Padova, Italy
- IOV Padova
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Parma, Italy
- Azienda Ospedaliero-Universitaria di Parma
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Ravenna, Italy
- UO Ematologia Ravenna
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Reggio Emilia, Italy
- Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia
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Rimini, Italy
- Ospedale Infermi Ematologia Rimini
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Rionero in Vulture, Italy
- IRCCS/CROB Rionero in Vulture
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Roma, Italy
- Istituto Regina Elena, Roma, IFO
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Terni, Italy
- SC Oncoematologia Terni
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Torino, Italy
- SC Ematologia Torino-Molinette
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Torino, Italy
- Torino Università, Ematologia 1, AO Città della Salute e della Scienza
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Bellinzona, Switzerland, 6500
- IOSI - Oncology Institute of Southern Switzerland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site 1.1 The following patients with gastric MALT Lymphoma can be entered:
- H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including
- Patients with clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication
- Stable disease with persistent lymphoma at ≥ 1 year post H. pylori eradication
- Relapse (without H. pylori re-infection), after a remission
- Patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy) 1.2 Similar consideration may be applied to patients with ocular adnexal lymphoma treated with antibiotics.
- Measurable or evaluable disease. Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with > 1.5 cm in longest transverse diameter or the short diameter must measure > 10 mm regardless of the longest transverse diameter.
- Any stage (Ann Arbor I-IV) (see Appendix A)
- Age ≥ 18
- Life expectancy of at least 1 year
- ECOG performance status 0-2 (see Appendix B)
- Adequate bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
- Adequate kidney (serum creatinine <1,5x upper normal) and liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement
- For women of childbearing potential only: negative serum pregnancy test done within 7 days prior to study drugs administration or within 14 days if with a confirmatory urine pregnancy test within 7 days prior to the first study drugs administration
Fertile male or female patients of childbearing potential and their partners must use two forms of contraception during the study and for at least 12 months after the last dose of subcutaneous rituximab.
For appropriate methods of contraception considered acceptable, see Appendix C. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study and for 12 months after study participation, the patient should inform the treating physician immediately.
Female patients of childbearing potential are defined as follows:
- Pre-menopausal women (patients with regular menstruation, patients after menarche with amenorrhea or irregular cycles, patients using a contraceptive method that precludes withdrawal bleeding
- Women who have had tubal ligation
Female patients may be considered to NOT be of childbearing potential for the following reasons:
- The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy
- The patient is medically confirmed to be menopausal (no menstrual period) for 24 consecutive months
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Evidence of histologic transformation to a high grade lymphoma
- Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
- Prior chemotherapy
- Prior immunotherapy with any anti-CD20 monoclonal antibody
- Prior radiotherapy in the last 6 weeks
- Use of corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
- Evidence of symptomatic central nervous system (CNS) disease
- Evidence of active opportunistic infections
- Known HIV infection
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, confirmed by HC RIBA immunoblot assay on the same sample.
- Pregnant or lactating status
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Fertile men or women of childbearing potential who do not agree to use a highly effective measure of contraception (such as oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) throughout the study and for at least 12 months after the last dose of subcutaneous rituximab
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Chlorambucil, Rituximab i.v., Rituximab s.c.
Chlorambucil 6 mg/m2 daily p.o for 42 consecutive days (weeks 1-6) in combination with intravenous Rituximab 375mg/m2 on days 1, 8, 15 and 22 (day 1 of weeks 1, 2, 3 and 4). 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. Therefore subcutaneous Rituximab 1400mg every two months for 2 years (in total 12 injections). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete remission rate
Time Frame: week 25
|
week 25
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: week 25
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Response rate (Complete and partial remission rates) for all patients
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week 25
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Event-free-survival (EFS)
Time Frame: at 5 years
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at 5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Emanuele Zucca, MD, IOSI Oncology Institute of Southern Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Lymphoma, B-Cell
- Lymphoma
- Stomach Neoplasms
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell, Marginal Zone
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Rituximab
- Chlorambucil
Other Study ID Numbers
- IELSG38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MALT Lymphoma
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National Taiwan University HospitalNot yet recruitingAntibiotics-unresponsive MALT Lymphoma | Relapsed MALT Type Extranodal Marginal Zone B-Cell Lymphoma | Refractory Extranodal Marginal Zone B-Cell Lymphoma (MALT)Taiwan
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Grupo Español de Linfomas y Transplante Autólogo...Completed
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Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingPrimary Ocular Adnexal MALT Lymphoma
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; China Medical University Hospital; Chang... and other collaboratorsCompletedGastric MALT LymphomaTaiwan
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Medical University of ViennaCompleted
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Eisai Co., Ltd.CompletedGastric Low-grade MALT Lymphoma With Helicobacter Pylori PositiveJapan
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Medical University of ViennaCompleted
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