Phase I Trial of FLAGM with High Doses of Cytosine Arabinoside for Relapsed, Refractory Acute Myeloid Leukemia: Study of the Japan Adult Leukemia Study Group (JALSG)

  • Shuichi Miyawaki
  • Yasukazu Kawai
  • Akihiro Takeshita
  • Norio Komatsu
  • Noriko Usui
  • Yukihiro Arai
  • Fumihiro Ishida
  • Takeshi Morii
  • Yasuhiko Kano
  • Michinori Ogura
  • Noriko Doki
  • Ryuzo Ohno
Article

DOI: 10.1532/IJH97.07072

Cite this article as:
Miyawaki, S., Kawai, Y., Takeshita, A. et al. Int J Hematol (2007) 86: 343. doi:10.1532/IJH97.07072

Abstract

This study was designed to determine the optimal high dose for cytosine arabinoside (ara-C) in combination with fludarabine, granulocyte colony-stimulating factor, and mitoxantrone (FLAGM) in adult patients with relapsed or refractory acute myeloid leukemia. Nine patients were enrolled at increasing dosage levels of ara-C (8,12, and 16 g/m2 per dose level). Ara-C and fludarabine were administered once a day at level 1, once or twice a day at level 2, and twice a day at level 3. All patients had grade 4 hematologic toxicity.The most common adverse events were of grade 2 or less, with nausea and vomiting being the most common (6 events), followed by diarrhea (5 events), and rash (5 events). Of the 13 grade 3 nonhematologic toxicities reported, the 2 most common were febrile neutropenia (6 events) and disseminated intravascular coagulation (3 events). No early deaths were observed. FLAGM with high-dose ara-C was considered safe for patients, and the recommended dosage of ara-C in this study was 2 g/m2 every 12 hours for a total dose of 16 g/m2.

Key words

AML Ara-C FLAGM therapy Cytarabine High-dose ara-C Phase I study 

Copyright information

© The Japanese Society of Hematology 2007

Authors and Affiliations

  • Shuichi Miyawaki
    • 1
  • Yasukazu Kawai
    • 2
  • Akihiro Takeshita
    • 3
  • Norio Komatsu
    • 4
  • Noriko Usui
    • 5
  • Yukihiro Arai
    • 6
  • Fumihiro Ishida
    • 7
  • Takeshi Morii
    • 8
  • Yasuhiko Kano
    • 9
  • Michinori Ogura
    • 10
  • Noriko Doki
    • 1
  • Ryuzo Ohno
    • 11
  1. 1.Leukemia Research CenterSaiseikai Maebashi HospitalGunmaJapan
  2. 2.Divison of Hematology and Oncology University of Fukui HospitalFukuiJapan
  3. 3.Department of Medicine IIIHamamatsu University School of MedicineShizuokaJapan
  4. 4.Division of Hematology, Department of Internal MedicineJichi Medical UniversityTochigiJapan
  5. 5.Division of Oncology and Hematology, Department of Internal MedicineThe Jikei University School of MedicineTokyoJapan
  6. 6.Department of HematologyDokkyo Medical University School of MedicineTochigiJapan
  7. 7.2nd Department of Internal MedicineShinshu University School of MedicineNaganoJapan
  8. 8.2nd Department of Internal MedicineNara Medical UniversityNaraJapan
  9. 9.Division of HematologyTochigi Cancer CenterTochigiJapan
  10. 10.Department of Hematology and Cell TherapyAichi Cancer CenterAichiJapan
  11. 11.Aichi Cancer CenterAichiJapan

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