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

Phase 2
18 Years
80 Years
Open (Enrolling)
MALT Lymphoma

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Rate of objective responses induced by Lenalidomide

Outcome Time Frame:

24 months

Safety Issue:



Austria: Agency for Health and Food Safety

Study ID:




Start Date:

July 2009

Completion Date:

June 2011

Related Keywords:

  • MALT Lymphoma
  • MALT lymphoma
  • Advanced or Helicobacter pylori-refractory MALT lymphoma
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone