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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Medical University of Vienna

Brief Summary:
The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (MALT).

Condition or disease Intervention/treatment Phase
MALT Lymphoma Drug: Lenalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Study Start Date : July 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lenalidomide
Lenalidomide administered orally at a dose of 25 mg daily
Drug: Lenalidomide
25 mg Lenalidomide p.o. daily for 21 days

Primary Outcome Measures :
  1. Rate of objective responses induced by Lenalidomide [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00923663

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Contact: Markus Raderer, MD +43-1-40400 ext 2296

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Dept of Internal Medicine Recruiting
Vienna, Austria, A-1090
Contact: Markus Raderer, MD    +43-1-40400 ext 2296   
Principal Investigator: Markus Raderer, MD         
Sponsors and Collaborators
Medical University of Vienna
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof Markus Raderer, Internal Medicine I, Division of Oncology, University of Vienna Identifier: NCT00923663    
Other Study ID Numbers: LEN-MALT
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010
Keywords provided by Medical University of Vienna:
MALT lymphoma
Advanced or Helicobacter pylori-refractory MALT lymphoma
Additional relevant MeSH terms:
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Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents