Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma
Phase II, multi-centric, open-label, study.
Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma|
- Event free survival (EFS) [ Time Frame: EFS post treatment (at 2 years) ]
- Objective disease response (CR, CRu and PR), SD and disease progression [ Time Frame: OS after treatment ]
- Duration of response [ Time Frame: Time interval from the date on which a response (CR, CRu and PR) ]
- Time to disease progression [ Time Frame: Time interval from the date from initial of study treatment until the date on which disease progression is documented ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||July 2018|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
Consolidation : Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
Other Name: consolidation
Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study).
Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906841
|Nantes, France, 44093|
|Principal Investigator:||Françoise KRAEBER BODERE, MDPD||French Innovative Leukemia Organisation|
|Principal Investigator:||Pierre SOUBEYRAN, MD||French Innovative Leukemia Organisation|