Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00906841|
Recruitment Status : Terminated (completed recruitment of patients on 15 december 2010)
First Posted : May 21, 2009
Last Update Posted : March 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma||Drug: 90Y-DOTA-hLL2||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||July 2018|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906841
|Nantes, France, 44093|
|Principal Investigator:||Françoise KRAEBER BODERE, MDPD||French Innovative Leukemia Organisation|
|Principal Investigator:||Pierre SOUBEYRAN, MD||French Innovative Leukemia Organisation|