Overview

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

Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (MALT).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Treatments:
Lenalidomide
Thalidomide
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