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Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01611259
First received: May 18, 2012
Last updated: March 11, 2015
Last verified: March 2015
  Purpose
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 Intervention Phase
Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Drug: Rituximab and Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Objective responses in patients with MALT lymphoma presenting with measureable disease [ Time Frame: At screening, after 3, 6, and 8 cycles (cycle duration 28 days) ]
    Capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with MALT lymphoma


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 50
Study Start Date: May 2012
Study Completion Date: February 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611259

Locations
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
  More Information

Additional Information:
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01611259     History of Changes
Other Study ID Numbers: AGMT_MALT2
Study First Received: May 18, 2012
Last Updated: March 11, 2015

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
MALT Lymphoma
Lenalidomide
Rituximab

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Rituximab
Thalidomide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 28, 2017