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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

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ClinicalTrials.gov Identifier: NCT01611259
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Condition or disease Intervention/treatment Phase
Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Drug: Rituximab and Lenalidomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Study Start Date : May 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Rituximab and Lenalidomide
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
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 Measures :
  1. Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease [ Time Frame: 40 weeks ]
    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 :
  1. Number and Severity of Adverse Events [ Time Frame: From treatment start until 28 days after last study treatment; expected study duration 24 months ]
    Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population

  2. Influence of Rituximab Plus Lenalidomide on T-cell Subsets [ Time Frame: Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 ]
    T-cell subsets will be evaluated from EDTA blood in a central lab



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611259


Locations
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Austria
AKH Linz
Linz, Oberösterreich, Austria, 4021
Klin.Abt.f. Hämatologie; Med.Univ.Graz
Graz, Austria, A-8036
Univ.-Klinik f. Innere Medizin V
Innsbruck, Austria, A-6020
PMU Salzburg
Salzburg, Austria, 5020
Universitätsklinik f. Innere Medizin I
Vienna, Austria, 1190
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
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Principal Investigator: Markus Raderer, MD Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus

Additional Information:
Publications of Results:
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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01611259     History of Changes
Other Study ID Numbers: AGMT_MALT2
First Posted: June 4, 2012    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
MALT Lymphoma
Lenalidomide
Rituximab
AGMT

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors