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Lymphoma, MalignantPhase 2MIRNCT00509184

Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

A Phase 2 study testing Rituximab in people with Lymphoma, Malignant, run by Klaus Herfarth, MD at 17 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lymphoma, Malignant
What is being tested?
Rituximab
How many people
85 participants
Where
17 sitesGermany
Study dates
Mar 2008to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • severe psychiatric disease
  • pregnancy or breast feeding
  • known allergies against foreign proteins

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Germany17 sites

  • Charité Campus Mitte

    Berlin, 10117

  • Charité Campus Benjamin-Franklin

    Berlin, 12200

  • Charité Campus Buch

    Berlin

  • University of Cologne

    Cologne, 50924

  • University of Dresden

    Dresden, 01307

  • University of Essen

    Essen, 45122

  • University of Göttingen

    Göttingen, 37075

  • University of Hannover

    Hanover, 30625

  • University of Heidelberg

    Heidelberg, 69120

  • University of Kiel

    Kiel, 24116

  • University of Mainz

    Mainz, 55101

  • University of Heidelberg (Campus Mannheim)

    Mannheim, 68167

  • University of Marburg

    Marburg, 35033

  • LMU

    Munich, 81377

  • TU

    Munich, 81675

  • University of Münster

    Münster, 48129

  • University of Ulm

    Ulm, 89081

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Rituximab
Keywords
untreated
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: 2 years

Secondary outcomes (6)

  1. Response to Rituximab

    Measured: 7 weeks

  2. Rate of CR

    Measured: 18 weeks

  3. Toxicity (CTC Vers. 3)

    Measured: 2 yrs

  4. Relapse rate, Relapse pattern, DSF

    Measured: 2 yrs

  5. Overall survival

    Measured: 2 yrs

  6. QoL

    Measured: 2 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2007 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509184
Sponsor's protocol ID
MIR 2006-001212-72
Acronym
MIR
Status last verified
Jan 2020
First submitted
30 Jul 2007
Last updated
6 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21352561

  • 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.

    PubMed 31723798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Lymphoma, Malignant, run by Klaus Herfarth, MD at 17 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.

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