NCT00509184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

5.1 years

First QC Date

July 30, 2007

Last Update Submit

January 2, 2020

Conditions

Lymphoma, Malignant

Keywords

untreated

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2 years

Secondary Outcomes (6)

  • Response to Rituximab

    7 weeks

  • Rate of CR

    18 weeks

  • Toxicity (CTC Vers. 3)

    2 yrs

  • Relapse rate, Relapse pattern, DSF

    2 yrs

  • Overall survival

    2 yrs

  • +1 more secondary outcomes

Interventions

RituximabDRUG

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Charité Campus Mitte

Berlin, 10117, Germany

Location

Charité Campus Benjamin-Franklin

Berlin, 12200, Germany

Location

Charité Campus Buch

Berlin, Germany

Location

University of Cologne

Cologne, 50924, Germany

Location

University of Dresden

Dresden, 01307, Germany

Location

University of Essen

Essen, 45122, Germany

Location

University of Göttingen

Göttingen, 37075, Germany

Location

University of Hannover

Hanover, 30625, Germany

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

University of Kiel

Kiel, 24116, Germany

Location

University of Mainz

Mainz, 55101, Germany

Location

University of Heidelberg (Campus Mannheim)

Mannheim, 68167, Germany

Location

University of Marburg

Marburg, 35033, Germany

Location

LMU

Munich, 81377, Germany

Location

TU

Munich, 81675, Germany

Location

University of Münster

Münster, 48129, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (2)

  • 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 Feb 26;11:87. doi: 10.1186/1471-2407-11-87.

    PMID: 21352561BACKGROUND

  • Herfarth K, Borchmann P, Schnaidt S, Hohloch K, Budach V, Engelhard M, Viardot A, Engenhart-Cabillic R, Keller U, Reinartz G, Eich HT, Witzens-Harig M, Hess CF, Dorken B, Durig J, Wiegel T, Hiddemann W, Hoster E, Pott C, Dreyling M. Rituximab With Involved Field Irradiation for Early-stage Nodal Follicular Lymphoma: Results of the MIR Study. Hemasphere. 2018 Nov 30;2(6):e160. doi: 10.1097/HS9.0000000000000160. eCollection 2018 Dec.

    PMID: 31723798RESULT

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Klaus Herfarth, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. K. Herfarth

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

March 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

DE(17)