Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Clinical Trial
Official title:
Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
| Verified date | June 2017 |
| Source | Arbeitsgemeinschaft medikamentoese Tumortherapie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | February 2015 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Klin.Abt.f. Hämatologie; Med.Univ.Graz | Graz | |
| Austria | Univ.-Klinik f. Innere Medizin V | Innsbruck | |
| Austria | AKH Linz | Linz | Oberösterreich |
| Austria | PMU Salzburg | Salzburg | |
| Austria | Universitätsklinik f. Innere Medizin I | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Arbeitsgemeinschaft medikamentoese Tumortherapie |
Austria,
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 l — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy. | 40 weeks | |
| Secondary | Number and Severity of Adverse Events | Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population | From treatment start until 28 days after last study treatment; expected study duration 24 months | |
| Secondary | Influence of Rituximab Plus Lenalidomide on T-cell Subsets | T-cell subsets will be evaluated from EDTA blood in a central lab | Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 |