Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

NCT01611259 | Completed Phase 2 Results

• 1 other identifier: AGMT_MALT2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Keywords

MALT Lymphoma; Lenalidomide; Rituximab; AGMT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number and Severity of Adverse Events

  From treatment start until 28 days after last study treatment; expected study duration 24 months

• Influence of Rituximab Plus Lenalidomide on T-cell Subsets

  Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5

Study Arms (1)

Rituximab and Lenalidomide

EXPERIMENTAL

Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days

Drug: Rituximab and Lenalidomide

Interventions

Rituximab and Lenalidomide DRUG

Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.

Rituximab and Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (5)

AKH Linz

Linz, Upper Austria, 4021, Austria

Location

Klin.Abt.f. Hämatologie; Med.Univ.Graz

Graz, A-8036, Austria

Location

Univ.-Klinik f. Innere Medizin V

Innsbruck, A-6020, Austria

Location

PMU Salzburg

Salzburg, 5020, Austria

Location

Universitätsklinik f. Innere Medizin I

Vienna, 1190, Austria

Location

Related Publications (1)

• 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.

  PMID: 27879257 RESULT

Related Links

• Sponsor

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Public contact Daniela Wolkersdorfer
• Organization: AGMT

d.wolkersdorfer@agmt.at

00436626404411

Study Officials

• Markus Raderer, MD

  Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: June 4, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)