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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoid
  • Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

NCT number NCT02577094
Study type Interventional
Source Nantes University Hospital
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Completion date January 2017