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Completed

NCT Number: NCT00509184

Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

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.

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Key information

Conditions

Lymphoma, Malignant Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Campus Benjamin-Franklin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap

Primary outcomes

  1. progression free survival

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Klaus Herfarth, MD

Other

Collaborators

  • German Low Grade Lymphoma Study Group
  • Roche Pharma AG

Registry information

Official study title

Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab

Acronym: MIR

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2007
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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