Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL

Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell–engaging bispecific Ab construct induced an 80% MRD r...

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Published inBlood Vol. 120; no. 26; pp. 5185 - 5187
Main Authors Topp, Max S., Gökbuget, Nicola, Zugmaier, Gerhard, Degenhard, Evelyn, Goebeler, Marie-Elisabeth, Klinger, Matthias, Neumann, Svenja A., Horst, Heinz A., Raff, Thorsten, Viardot, Andreas, Stelljes, Matthias, Schaich, Markus, Köhne-Volland, Rudolf, Brüggemann, Monika, Ottmann, Oliver G., Burmeister, Thomas, Baeuerle, Patrick A., Nagorsen, Dirk, Schmidt, Margit, Einsele, Hermann, Riethmüller, Gert, Kneba, Michael, Hoelzer, Dieter, Kufer, Peter, Bargou, Ralf C.
Format Journal Article
LanguageEnglish
Published Washington, DC Elsevier Inc 20.12.2012
Americain Society of Hematology
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Summary:Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell–engaging bispecific Ab construct induced an 80% MRD response rate. In the present study, we show that after a median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable study cohort of 20 patients was 61% (Kaplan-Meier estimate). The hema-tologic relapse-free survival rate of a subgroup of 9 patients who received allogeneic hematopoietic stem cell transplantation after blinatumomab treatment was 65% (Kaplan-Meier estimate). Of the subgroup of 6 Philadelphia chromosome–negative MRD responders with no further therapy after blinatumomab, 4 are in ongoing hematologic and molecular remission. We conclude that blinatumomab can induce long-lasting complete remission in B-lineage ALL patients with persistent or recurrent MRD. The original study and this follow-up study are registered at www.clinicaltrials.gov as NCT00198991 and NCT00198978, respectively.
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ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2012-07-441030