Clinical trial NCT01611259: Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
Official title: Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Keywords: MALT Lymphoma
Lenalidomide
Rituximab
AGMT
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.


Eligibility criteria: Inclusion Criteria selected:

* Histologically verified diagnosis if MALT lymphoma of any localization
* Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
* Ann Arbor Stage I-IV
* In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
* ECOG performance status of 0,1 or 2
* Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin

Exclusion Criteria selected:

* 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 or myocardial infarction within the last 6 months
* Known hypersensitivity to thalidomide or lenalidomide or rituximab

Primary outcomes:
measure: Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
timeFrame: 40 weeks
Secondary outcomes:
measure: Number and Severity of Adverse Events
timeFrame: From treatment start until 28 days after last study treatment; expected study duration 24 months
measure: Influence of Rituximab Plus Lenalidomide on T-cell Subsets
timeFrame: Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKH Linz
state: Oberösterreich
city: Graz
country: Austria
facility: Klin.Abt.f. Hämatologie; Med.Univ.Graz
city: Innsbruck
country: Austria
facility: Univ.-Klinik f. Innere Medizin V
city: Salzburg
country: Austria
facility: PMU Salzburg
city: Vienna
country: Austria
facility: Universitätsklinik f. Innere Medizin I
Study officials:
affiliation: Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus
name: Markus Raderer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiesewetter B, Willenbacher E, Willenbacher W, Egle A, Neumeister P, Voskova D, Mayerhoefer ME, Simonitsch-Klupp I, Melchardt T, Greil R, Raderer M; AGMT Investigators. A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma. Blood. 2017 Jan 19;129(3):383-385. doi: 10.1182/blood-2016-06-720599. Epub 2016 Nov 22. No abstract available.