PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
|ClinicalTrials.gov Identifier: NCT00544219|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : May 15, 2019
RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Procedure: positron emission tomography||Not Applicable|
- To evaluate if an early positive positron emission tomography (PET) scan after 2 courses of rituximab with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone can be used to identify a group of patients having a poor prognosis.
- To compare modified PET/CT scan response criteria with revised standard response criteria.
- To evaluate, in a prospective manner, whether a proliferation-inducing ligand (APRIL) expression is a prognostic factor in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Rituximab IV alone is continued for an additional 2 courses after completion of the initial 6 courses.
Patients undergo positron emission tomography (PET) scan prior to and after completion of study therapy. Patients also undergo PET scan after course 2, and those with a positive PET result undergo an additional PET scan after course 4.
Previously collected tumor samples are analyzed for a proliferation-inducing ligand (APRIL) expression.
After completion of study treatment, patients are followed periodically for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||January 2016|
375 mg/m2 i.v. per cycle
Other Name: Mabthera
750 mg/m2 i.v. per cycle
Other Name: Endoxan
Drug: doxorubicin hydrochloride
50 mg/m2 i.v. per cycle
Other Name: Adriamycin, Adriblastin
100 mg/day p.o. per cycle
Other Name: Deltasone, Orasone
Drug: vincristine sulfate
1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
Other Name: Oncovin
Procedure: positron emission tomography
PET Scan during treatment
- Event-free survival [ Time Frame: at 2 years ]
- Event-free survival [ Time Frame: at 5 years ]
- Overall survival during follow-up [ Time Frame: at 2 and 5 years ]
- Objective response [ Time Frame: at 2 years ]
- Positron emission tomography (PET) results [ Time Frame: at 2 years ]
- Histological results of remaining PET-positive lesion(s) after treatment [ Time Frame: at 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544219
|Study Chair:||Christoph Mamot, MD||Kantonsspital Aarau|
|Study Chair:||Mario Bargetzi, MD||Kantonsspital Aarau|
|Study Chair:||Giovanni Martinelli, MD||European Institute of Oncology|