Clinical trial NCT00923663: Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Official title: Phase II Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: MALT Lymphoma
Keywords: MALT lymphoma
Advanced or Helicobacter pylori-refractory MALT lymphoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of objective responses induced by Lenalidomide
timeFrame: 24 months
Secondary outcomes:
measure: Time to progression
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept of Internal Medicine
Study officials:
References:
citation: 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.