NCT00923663

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

1.9 years

First QC Date

June 17, 2009

Last Update Submit

September 27, 2010

Conditions

MALT Lymphoma

Keywords

MALT lymphomaAdvanced or Helicobacter pylori-refractory MALT lymphoma

Outcome Measures

Primary Outcomes (1)

  • Rate of objective responses induced by Lenalidomide

    24 months

Secondary Outcomes (1)

  • Time to progression

    24 months

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide administered orally at a dose of 25 mg daily

Drug: Lenalidomide

Interventions

LenalidomideDRUG

25 mg Lenalidomide p.o. daily for 21 days

Lenalidomide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Internal Medicine

Vienna, A-1090, Austria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22899582DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Markus Raderer, MD

CONTACT

+43-1-40400markus.raderer@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

AU(1)