Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F18%3A00103867" target="_blank" >RIV/00216224:14110/18:00103867 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1038/s41375-018-0210-1" target="_blank" >http://dx.doi.org/10.1038/s41375-018-0210-1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1038/s41375-018-0210-1" target="_blank" >10.1038/s41375-018-0210-1</a>
Alternative languages
Result language
angličtina
Original language name
Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia
Original language description
This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had >= 2 prior systemic therapies, including >= 1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 mu g/kg intravenously on days 1, 3, and 5 every 28 days for <= 6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30205 - Hematology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Leukemia
ISSN
0887-6924
e-ISSN
1476-5551
Volume of the periodical
32
Issue of the periodical within the volume
8
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
1768-1777
UT code for WoS article
000441284000009
EID of the result in the Scopus database
2-s2.0-85050272095