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

Lymphoma, Follicular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915096
• Other study ID #: PET-FOL
• Status: Completed
• Start date: September 18, 2007
• Est. completion date: February 8, 2013

Study information

• Verified date: August 2018
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 8, 2013
• Est. primary completion date: May 10, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
France	CHU - Besançon	Besançon
France	CHU Avicenne	Bobigny
France	Centre Bergognié	Bordeaux
France	Hôpital Henri Mondor	Créteil
France	CHU de Dijon	Dijon
France	Clinique Victor Hugo	Le Mans
France	Centre Hospitalier - Lens	Lens
France	CHRU Lille	Lille
France	CHU - Limoges	Limoges
France	Centre Paoli-Calmettes	Marseille
France	CHU - Nantes	Nantes
France	Hôpital Necker	Paris
France	Hôpital Pitié-Salpêtrière	Paris
France	Hôpital Saint-Louis	Paris
France	CHU Lyon Sud	Pierre Benite
France	CHU Robert Debré	Reims
France	Centre Henri Becquerel	Rouen
France	CHU Purpan	Toulouse
France	Hôpital Bretonneau	Tours
France	CHU Brabois	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif
Italy	Ospedale Cuneo	Cuneo

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Study Association

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of PET on progression-free survival		2 years
Secondary	Comparison of PET results to treatment response (Cheson criteria)		30 weeks
Secondary	Correlation of PET data with FLIPI index score		Baseline
Secondary	Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation		30 weeks
Secondary	Correlation of PET data with histopathological data (including the use of immunohistochemical markers)		Baseline
Secondary	Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow		Baseline
Secondary	Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria		30 weeks

External Links

•   GELA