Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT02577094
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPRALLO
Brief Summary:
Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2 before allogeneic stem cell transplantation.
Detailed Description:
* Physical examination (screening and follow-up)
* Complete blood counts (screening and follow-up)
* Dosage of FLT3-ligand in plasma (screening and follow-up)
* Blood ionogramme, creatinine hepatic work-up (screening and follow-up)
* Left ventricular ejection fraction at pre-implant assessment
* Immunization test (screening and follow-up)
* Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)
* All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.
* Pharmacokinetic of 90Y-hLL2
* Complete blood counts (screening and follow-up)
* Dosage of FLT3-ligand in plasma (screening and follow-up)
* Blood ionogramme, creatinine hepatic work-up (screening and follow-up)
* Left ventricular ejection fraction at pre-implant assessment
* Immunization test (screening and follow-up)
* Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)
* All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.
* Pharmacokinetic of 90Y-hLL2
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: