Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00906841|
Recruitment Status : Terminated (completed recruitment of patients on 15 december 2010)
First Posted : May 21, 2009
Last Update Posted : April 27, 2018
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|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|