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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Medical University of Vienna.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00923663

First received: June 17, 2009

Last updated: September 27, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2009

Last Updated Date

September 27, 2010

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of objective responses induced by Lenalidomide [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

MALT Lymphoma

Intervention ^ICMJE

Drug: Lenalidomide

25 mg Lenalidomide p.o. daily for 21 days

Study Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Markus Raderer, MD

+43-1-40400 ext 2296

markus.raderer@meduniwien.ac.at

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00923663

Other Study ID Numbers ^ICMJE

LEN-MALT

Has Data Monitoring Committee

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

Information Provided By

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

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