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Lymphoma, FollicularNCT00915096

Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma

An observational study of Lymphoma, Follicular, run by Lymphoma Study Association at 22 sites in 2 countries.

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

The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, Follicular
How many people
121 participants
Where
22 sitesin 2 countries
Study dates
18 Sep 2007to 8 Feb 2013
Phase
Observational
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: High Tumor Burden Follicular Lymphoma patients

Who may be able to join

  • Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
  • Patients who have not previously been treated for this disease,
  • Introducing one of the criteria for high tumor burden,
  • Patients aged over 18 and under 80 years,
  • Patients whose ECOG condition is ≤ 2,
  • Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
  • Patient had the PET examination less than a month before the start of chemotherapy.

Who cannot join

  • Patients with lymphoma who have already transformed or been treated for this disease,
  • Patients whose lymphoma is stage 3b,
  • Patients with impaired central nervous system,
  • Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
  • Patients who have undergone major surgery during the 28 days preceding the inclusion,
  • Patients with low kidney and/or liver function,
Show all 12Show fewer
  • Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
  • Patients whose life expectancy ≤ 6 months,
  • Patients sensitive or allergic to murine products,
  • Patients who participated in another clinical trial during the 30 days preceding the recording,
  • Patients with other medical problems or psychological succeptibles interfere with the study,
  • Patients under adult supervision.

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

France21 sites

  • CHU - Besançon

    Besançon

  • CHU Avicenne

    Bobigny

  • Centre Bergognié

    Bordeaux

  • Hôpital Henri Mondor

    Créteil

  • CHU de Dijon

    Dijon, 21034

  • Clinique Victor Hugo

    Le Mans

  • Centre Hospitalier - Lens

    Lens

  • CHRU Lille

    Lille, 59037

  • CHU - Limoges

    Limoges

  • Centre Paoli-Calmettes

    Marseille

  • CHU - Nantes

    Nantes

  • Hôpital Necker

    Paris

  • Hôpital Pitié-Salpêtrière

    Paris

  • Hôpital Saint-Louis

    Paris

  • CHU Lyon Sud

    Pierre-Bénite, 69310

  • CHU Robert Debré

    Reims

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU Purpan

    Toulouse

  • Hôpital Bretonneau

    Tours

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Italy1 site

  • Ospedale Cuneo

    Cuneo

Other trials in Italy

About this study

Official title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.

Keywords
Follicular Lymphoma, PET, GELA
Medical subject headings
Lymphoma, Follicular

What participants receive

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

Study groups in NCT00915096
Study groupRoleWhat they receive
High Tumor Burden Follicular LymphomaNot described

What is being measured

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

  1. Predictive value of PET on progression-free survival

    Measured: 2 years

Secondary outcomes (6)

  1. Comparison of PET results to treatment response (Cheson criteria)

    Measured: 30 weeks

  2. Correlation of PET data with FLIPI index score

    Measured: Baseline

  3. Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation

    Measured: 30 weeks

  4. Correlation of PET data with histopathological data (including the use of immunohistochemical markers)

    Measured: Baseline

  5. Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow

    Measured: Baseline

  6. Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria

    Measured: 30 weeks

Timeline

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

  1. First posted5 Jun 2009 (estimated)
  2. Study start18 Sep 2007
  3. Primary completion10 May 2011
  4. Study completion8 Feb 2013

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00915096
Sponsor's protocol ID
PET-FOL
Status last verified
Aug 2018
First submitted
4 Jun 2009
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.

    PubMed 23109699

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, Follicular, run by Lymphoma Study Association at 22 sites in 2 countries.

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 7 inclusion and 12 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France, Italy. 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.

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?

Predictive value of PET on 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 NCT00915096, which also lists 1 linked publication.

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 23 Aug 2018.

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