Open-label, Multicenter Phase II Study to Investigate the Efficacy, Safety, and Tolerability of the Bispecific T-cell Engager (BiTE®) MT103 in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia
The presence of leukemia cells below the cytological detection limit (5% leukemic cells) is
defined as minimal residual disease (MRD). If no MRD is detectable (<10-4 =< 1 leukemia cell
per 104 bone marrow cells) a complete molecular remission is reached. In the last years a
series of retrospective studies has shown that MRD in adult ALL is an independent prognostic
factor as already demonstrated for childhood leukemia. Diagnostic tools for MRD are
polymerase chain reaction (PCR) and/or flow cytometry. PCR analysis can detect fusion
transcripts such as bcr/abl and individual clonal rearrangements of immu-noglobulins (IgH)
and/or T-cell receptor genes (TCR). About 25% of patients with MRD defined by rearrangement
comprise a high-risk group with a 94% relapse rate within 3 years. In general for patients
with MRD, who are not eligible for allogenic stem cell transplantation, curative treatment
is not available. This accounts for MRD defined by the Philadelphia chromosome translocation
as well as for MRD defined by rearrangement. The current study is set up to address the
question of treating MRD positive ALL with the bispecific anti-CD19 x anti-CD3 antibody
derivative Blinatumomab (MT103).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MRD response rate defined by the incidence of MRD negativity
within 24 weeks
No
Ralf Bargou, Professor
Principal Investigator
Julius-Maximilians-Universität Würzburg
Germany: Paul-Ehrlich-Institut
MT103-202
NCT00560794
October 2007
December 2014
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