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
NCT number | NCT00915096 |
Other study ID # | PET-FOL |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 18, 2007 |
Est. completion date | February 8, 2013 |
Verified date | August 2018 |
Source | Lymphoma Study Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Lymphoma Study Association |
France, Italy,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01950273 -
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT00930514 -
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT02472756 -
Open, Noninterventional Trial of MabThera in Combination With Chemotherapy (CVP, CHOP or FCM) in Patients With Relapsed/Refractory Follicular Lymphoma
|
N/A | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00193492 -
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
|
Phase 2 | |
Withdrawn |
NCT00092274 -
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT03087929 -
Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
|
N/A | |
Terminated |
NCT02413489 -
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
|
Phase 2 | |
Recruiting |
NCT05849857 -
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
|
Phase 2 | |
Recruiting |
NCT05410418 -
Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
|
Phase 2 | |
Terminated |
NCT01609036 -
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma
|
N/A | |
Completed |
NCT01234766 -
Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT00849147 -
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
|
Phase 2 | |
Terminated |
NCT00384111 -
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Completed |
NCT03682796 -
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
|
Phase 1 | |
Recruiting |
NCT04982471 -
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
|
||
Active, not recruiting |
NCT02996773 -
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
|
Phase 1 | |
Terminated |
NCT00562965 -
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Active, not recruiting |
NCT00317096 -
FCM Versus R-FCM Followed by R-Maintenance or Observation Only
|
Phase 3 | |
Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 |