Trial of Lenalidomide in Patients With Lymphoma of the Mu... | NCT00923663

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

NCT00923663

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Sep 28, 2010Estimated

Enrollment

16Estimated

Phase

Phase 2

Conditions

MALT Lymphoma

Interventions

Lenalidomide

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jun 17, 2009

First Posted Date

Jun 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2010

Last Update Posted Date

Sep 28, 2010Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Label	Type	Description	Intervention Names
Lenalidomide	Experimental	Lenalidomide administered orally at a dose of 25 mg daily	Drug: Lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	25 mg Lenalidomide p.o. daily for 21 days	Lenalidomide

Measure	Description	Time Frame
Rate of objective responses induced by Lenalidomide		24 months

Measure	Description	Time Frame
Time to progression		24 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Markus Raderer, MD	Contact	+43-1-40400	2296	markus.raderer@meduniwien.ac.at

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Internal Medicine	Recruiting	Vienna		A-1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22899582	Derived	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.

Type	Date	Date Unknown
Release	Mar 12, 2015
Reset	Mar 28, 2015

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids