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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

Tracking Information
First Submitted Date  ICMJE May 18, 2012
First Posted Date  ICMJE June 4, 2012
Results First Submitted Date  ICMJE June 21, 2016
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease
Capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with MALT lymphoma
Change History Complete list of historical versions of study NCT01611259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
Official Title  ICMJE Phase II Trial of Rituximab Plus Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Drug: Rituximab and Lenalidomide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2012)
46
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01611259
Other Study ID Numbers  ICMJE AGMT_MALT2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Sponsor  ICMJE Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus Raderer, MD Allgemeines Krankenhaus der Stadt Wien - Medizinischer Universitätscampus
PRS Account Arbeitsgemeinschaft medikamentoese Tumortherapie
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP