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Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma (MIR)

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ClinicalTrials.gov Identifier: NCT00509184
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Roche Pharma AG
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Study Description
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Brief Summary:
Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.

Condition or disease Intervention/treatment Phase
Lymphoma, Malignant Drug: Rituximab Phase 2

Detailed Description:

The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) in combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the study is progression free survival. Secondary endpoints are response rate to Rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life.

More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
Study Start Date : March 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Intervention Details:
  • Drug: Rituximab
    375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap

Outcome Measures
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Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Response to Rituximab [ Time Frame: 7 weeks ]
  2. Rate of CR [ Time Frame: 18 weeks ]
  3. Toxicity (CTC Vers. 3) [ Time Frame: 2 yrs ]
  4. Relapse rate, Relapse pattern, DSF [ Time Frame: 2 yrs ]
  5. Overall survival [ Time Frame: 2 yrs ]
  6. QoL [ Time Frame: 2 yrs ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • verified follicular lymphoma grade 1 or 2
  • only nodal involvement (incl. Waldeyer) clinical stage I or II
  • largest tumor ≤ 7 cm
  • adequate bone marrow reserves

Exclusion Criteria:

  • ECOG >2
  • Follicular lymphoma grade 3
  • buky disease (>7 cm)
  • involvement of the spleen
  • neoplasia in PMH (except: basalioma, spinalioma)
  • Immunodeficiency syndromes, viral hepatitis, connective tissue disease
  • severe psychiatric disease
  • pregnancy or breast feeding
  • known allergies against foreign proteins
Contacts and Locations
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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): NCT00509184


Locations
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Sponsors and Collaborators
Klaus Herfarth, MD
German Low Grade Lymphoma Study Group
Roche Pharma AG
Investigators
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Principal Investigator: Klaus Herfarth, MD Heidelberg University
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Klaus Herfarth, MD, Prof. Dr. K. Herfarth, Heidelberg University
ClinicalTrials.gov Identifier: NCT00509184    
Other Study ID Numbers: MIR 2006-001212-72
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Keywords provided by Klaus Herfarth, MD, Heidelberg University:
untreated
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents