Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
NCT ID: NCT00923663
Last Updated: 2010-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
16 participants
INTERVENTIONAL
2009-07-31
2011-06-30
Brief Summary
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Detailed Description
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The secondary objectives are to evaluate the safety of Lenalidomide in this patient population and to evaluate the impact of Lenalidomide on progression free survival.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide
Lenalidomide administered orally at a dose of 25 mg daily
Lenalidomide
25 mg Lenalidomide p.o. daily for 21 days
Interventions
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Lenalidomide
25 mg Lenalidomide p.o. daily for 21 days
Eligibility Criteria
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Inclusion Criteria
* With first or greater relapse after HP-eradication, radiation or chemotherapy in case of gastric lymphoma
* Age \> 18 years
* Must be able to tolerate therapy, and have adequate cardiac, renal, and hepatic function, ECOG status of 0 - 2
* Must be capable of understanding the purpose of the study and have given written informed consent
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 (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
* Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) \< 1.0 x 109/L
* Patients with active opportunistic infections
* Pregnancy
* Uncontrolled diabetes mellitus
* Preexisting thromboembolic events at start of study
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Internal Medicine I, Division of Oncology, University of Vienna
Locations
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Dept of Internal Medicine
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Kiesewetter B, Troch M, Dolak W, Mullauer L, Lukas J, Zielinski CC, Raderer M. A phase II study of lenalidomide in patients with extranodal marginal zone B-cell lymphoma of the mucosa associated lymphoid tissue (MALT lymphoma). Haematologica. 2013 Mar;98(3):353-6. doi: 10.3324/haematol.2012.065995. Epub 2012 Aug 16.
Other Identifiers
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LEN-MALT
Identifier Type: -
Identifier Source: org_study_id