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Completed

NCT Number: NCT00915096

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU - Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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.

Treatment and study plan

Primary outcomes

  1. Predictive value of PET on progression-free survival

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 30 weeks

  2. Correlation of PET data with FLIPI index score

    Time frame: Baseline

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

    Time frame: 30 weeks

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: 30 weeks

Sponsors and collaborators

Lead sponsor

Lymphoma Study Association

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Jun 5, 2009
Registry last updated
Aug 23, 2018

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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