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Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

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ClinicalTrials.gov Identifier: NCT00923663
Recruitment Status : Unknown
Verified September 2010 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE June 17, 2009
First Posted Date  ICMJE June 18, 2009
Last Update Posted Date September 28, 2010
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Rate of objective responses induced by Lenalidomide [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00923663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Time to progression [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Official Title  ICMJE Phase II Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Brief Summary The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (MALT).
Detailed Description

The primary objective of the study is to evaluate the clinical potential of Lenalidomide to induce objective/histologic responses in patients with MALT lymphoma.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE MALT Lymphoma
Intervention  ICMJE Drug: Lenalidomide
25 mg Lenalidomide p.o. daily for 21 days
Study Arms  ICMJE Experimental: Lenalidomide
Lenalidomide administered orally at a dose of 25 mg daily
Intervention: Drug: Lenalidomide
Publications * Kiesewetter B, Troch M, Dolak W, Müllauer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2009)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically confirmed MALT lymphoma with measurable disease (stage I - IV)
  • 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:

  • Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00923663
Other Study ID Numbers  ICMJE LEN-MALT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Markus Raderer, Internal Medicine I, Division of Oncology, University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP