Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
NCT ID: NCT01611259
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2012-05-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab and Lenalidomide
Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days
Rituximab and Lenalidomide
Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
Interventions
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Rituximab and Lenalidomide
Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
Eligibility Criteria
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Inclusion Criteria
* Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
* Ann Arbor Stage I-IV
* In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
* ECOG performance status of 0,1 or 2
* Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin
Exclusion Criteria
* Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
* History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 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
* Severe peripheral polyneuropathy
* Clinically significant cardiac disease or myocardial infarction within the last 6 months
* Known hypersensitivity to thalidomide or lenalidomide or rituximab
18 Years
ALL
No
Sponsors
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Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER
Responsible Party
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Principal Investigators
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Markus Raderer, MD
Role: PRINCIPAL_INVESTIGATOR
Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus
Locations
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AKH Linz
Linz, Upper Austria, Austria
Klin.Abt.f. Hämatologie; Med.Univ.Graz
Graz, , Austria
Univ.-Klinik f. Innere Medizin V
Innsbruck, , Austria
PMU Salzburg
Salzburg, , Austria
Universitätsklinik f. Innere Medizin I
Vienna, , Austria
Countries
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References
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Kiesewetter B, Willenbacher E, Willenbacher W, Egle A, Neumeister P, Voskova D, Mayerhoefer ME, Simonitsch-Klupp I, Melchardt T, Greil R, Raderer M; AGMT Investigators. A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma. Blood. 2017 Jan 19;129(3):383-385. doi: 10.1182/blood-2016-06-720599. Epub 2016 Nov 22. No abstract available.
Related Links
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Sponsor
Other Identifiers
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AGMT_MALT2
Identifier Type: -
Identifier Source: org_study_id