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Clofarabine, high-dose cytarabine and liposomal daunorubicin in pediatric relapsed/refractory acute myeloid leukemia: a phase IB study
NKA. van Eijkelenburg, M. Rasche, E. Ghazaly, MN. Dworzak, T. Klingebiel, C. Rossig, G. Leverger, J. Stary, ESJM. De Bont, DA. Chitu, Y. Bertrand, B. Brethon, B. Strahm, IM. van der Sluis, GJL. Kaspers, D. Reinhardt, CM. Zwaan,
Jazyk angličtina Země Itálie
Typ dokumentu klinické zkoušky, fáze I, časopisecké články, práce podpořená grantem
NLK
Directory of Open Access Journals
od 1994
Free Medical Journals
od 1994
Freely Accessible Science Journals
od 1994
PubMed Central
od 2009
Europe PubMed Central
od 2009
Open Access Digital Library
od 1994-01-01
ROAD: Directory of Open Access Scholarly Resources
od 1996
- MeSH
- akutní myeloidní leukemie diagnóza farmakoterapie mortalita MeSH
- analýza přežití MeSH
- chemorezistence MeSH
- cytarabin aplikace a dávkování farmakokinetika MeSH
- daunomycin aplikace a dávkování farmakokinetika MeSH
- dítě MeSH
- indukce remise MeSH
- klofarabin aplikace a dávkování farmakokinetika MeSH
- kojenec MeSH
- lidé MeSH
- liposomy MeSH
- mladiství MeSH
- mladý dospělý MeSH
- opakovaná terapie MeSH
- předškolní dítě MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- recidiva MeSH
- rozvrh dávkování léků MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze I MeSH
- práce podpořená grantem MeSH
Survival in children with relapsed/refractory acute myeloid leukemia is unsatisfactory. Treatment consists of one course of fludarabine, cytarabine and liposomal daunorubicin, followed by fludarabine and cytarabine and stem-cell transplantation. Study ITCC 020/I-BFM 2009-02 aimed to identify the recommended phase II dose of clofarabine replacing fludarabine in the abovementioned combination regimen (3+3 design). Escalating dose levels of clofarabine (20-40 mg/m2/day × 5 days) and liposomal daunorubicin (40-80 mg/m2/day) were administered with cytarabine (2 g/m2/day × 5 days). Liposomal DNR was given on day 1, 3 and 5 only. The cohort at the recommended phase II dose was expanded to make a preliminary assessment of anti-leukemic activity. Thirty-four children were enrolled: refractory 1st (n=11), early 1st (n=15), ≥2nd relapse (n=8). Dose level 3 (30 mg/m2clofarabine; 60 mg/m2liposomal daunorubicin) appeared to be safe only in patients without subclinical fungal infections. Infectious complications were dose-limiting. The recommended phase II dose was 40 mg/m2 clofarabine with 60 mg/m2 liposomal daunorubicin. Side-effects mainly consisted of infections. The overall response rate was 68% in 31 response evaluable patients, and 80% at the recommended phase II dose (n=10); 22 patients proceeded to stem cell transplantation. The 2-year probability of event-free survival (pEFS) was 26.5±7.6 and probability of survival (pOS) 32.4±8.0%. In the 21 responding patients, the 2-year pEFS was 42.9±10.8 and pOS 47.6±10.9%. Clofarabine exposure in plasma was not significantly different from that in single-agent studies. In conclusion, clofarabine was well tolerated and showed high response rates in relapsed/refractory pediatric acute myeloid leukemia. Patients with (sub) clinical fungal infections should be treated with caution. Clofarabine has been taken forward in the Berlin-Frankfurt-Münster study for newly diagnosed acute myeloid leukemia. The Study ITCC-020 was registered as EUDRA-CT 2009-009457-13; Dutch Trial Registry number 1880.
Centre for Haemato Oncology Barts Cancer Institute Queen Mary University of London UK
Clinical Trial Center Department of Hematology Erasmus Medical Center Rotterdam the Netherlands
Department of Pediatric Hematology and Oncology AP HP GH HUEP Trousseau Hospital Paris France
Department of Pediatric Hematology Robert Debré Hospital Paris France
Department of Pediatric Oncology University Children's Hospital Essen Germany
Pediatric Hematology and Oncology University Children's Hospital Münster Germany
Pediatric Hematology Department IHOP and Claude Bernard University Lyon France
Pediatric Hematology Oncology Johann Wolfgang Goethe University Frankfurt Germany
Citace poskytuje Crossref.org
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