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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Primary Purpose

Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Rituximab and Lenalidomide
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) focused on measuring MALT Lymphoma, Lenalidomide, Rituximab, AGMT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AKH Linz
  • Klin.Abt.f. Hämatologie; Med.Univ.Graz
  • Univ.-Klinik f. Innere Medizin V
  • PMU Salzburg
  • Universitätsklinik f. Innere Medizin I

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab and Lenalidomide

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number and Severity of Adverse Events
Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population
Influence of Rituximab Plus Lenalidomide on T-cell Subsets
T-cell subsets will be evaluated from EDTA blood in a central lab

Full Information

First Posted
May 18, 2012
Last Updated
June 19, 2017
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
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1. Study Identification

Unique Protocol Identification Number
NCT01611259
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Keywords
MALT Lymphoma, Lenalidomide, Rituximab, AGMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab and Lenalidomide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rituximab and Lenalidomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
Description
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.
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Number and Severity of Adverse Events
Description
Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population
Time Frame
From treatment start until 28 days after last study treatment; expected study duration 24 months
Title
Influence of Rituximab Plus Lenalidomide on T-cell Subsets
Description
T-cell subsets will be evaluated from EDTA blood in a central lab
Time Frame
Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Raderer, MD
Organizational Affiliation
Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Klin.Abt.f. Hämatologie; Med.Univ.Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Univ.-Klinik f. Innere Medizin V
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Universitätsklinik f. Innere Medizin I
City
Vienna
ZIP/Postal Code
1190
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27879257
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.
Results Reference
result
Links:
URL
http://www.agmt.at
Description
Sponsor

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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

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