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Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group.

Publication ,  Journal Article
Berg, SL; Blaney, SM; Devidas, M; Lampkin, TA; Murgo, A; Bernstein, M; Billett, A; Kurtzberg, J; Reaman, G; Gaynon, P; Whitlock, J; Krailo, M ...
Published in: J Clin Oncol
May 20, 2005

PURPOSE: Nelarabine (compound 506U78), a water soluble prodrug of 9-b-d-arabinofuranosylguanine, is converted to ara-GTP in T lymphoblasts. We sought to define the response rate of nelarabine in children and young adults with refractory or recurrent T-cell disease. PATIENTS AND METHODS: We performed a phase II study with patients stratified as follows: stratum 1: > or = 25% bone marrow blasts in first relapse; stratum 2: > or = 25% bone marrow blasts in > or = second relapse; stratum 3: positive CSF; stratum 4: extramedullary (non-CNS) relapse. The initial nelarabine dose was 1.2 g/m2 daily for 5 consecutive days every 3 weeks. There were two dose de-escalations due to neurotoxicity on this or other studies. The final dose was 650 mg/m2/d for strata 1 and two patients and 400 mg/m2/d for strata 3 and four patients. RESULTS: We enrolled 121 patients (106 assessable for response) at the final dose levels. Complete plus partial response rates at the final dose levels were: 55% in stratum 1; 27% in stratum 2; 33% in stratum 3; and 14% in stratum 4. There were 31 episodes of > or = grade 3 neurologic adverse events in 27 patients (18% of patients). CONCLUSION: Nelarabine is active as a single agent in recurrent T-cell leukemia, with a response rate more than 50% in first bone marrow relapse. The most significant adverse events associated with nelarabine administration are neurologic. Further studies are planned to determine whether the addition of nelarabine to front-line therapy for T-cell leukemia in children will improve survival.

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Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

May 20, 2005

Volume

23

Issue

15

Start / End Page

3376 / 3382

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Risk Assessment
  • Recurrence
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Maximum Tolerated Dose
  • Male
  • Leukemia, T-Cell
  • Infusions, Intravenous
 

Citation

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Berg, S. L., Blaney, S. M., Devidas, M., Lampkin, T. A., Murgo, A., Bernstein, M., … Children’s Oncology Group, . (2005). Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group. J Clin Oncol, 23(15), 3376–3382. https://doi.org/10.1200/JCO.2005.03.426
Berg, Stacey L., Susan M. Blaney, Meenakshi Devidas, Tom A. Lampkin, Anthony Murgo, Mark Bernstein, Amy Billett, et al. “Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group.J Clin Oncol 23, no. 15 (May 20, 2005): 3376–82. https://doi.org/10.1200/JCO.2005.03.426.
Berg SL, Blaney SM, Devidas M, Lampkin TA, Murgo A, Bernstein M, et al. Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group. J Clin Oncol. 2005 May 20;23(15):3376–82.
Berg, Stacey L., et al. “Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group.J Clin Oncol, vol. 23, no. 15, May 2005, pp. 3376–82. Pubmed, doi:10.1200/JCO.2005.03.426.
Berg SL, Blaney SM, Devidas M, Lampkin TA, Murgo A, Bernstein M, Billett A, Kurtzberg J, Reaman G, Gaynon P, Whitlock J, Krailo M, Harris MB, Children’s Oncology Group. Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group. J Clin Oncol. 2005 May 20;23(15):3376–3382.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

May 20, 2005

Volume

23

Issue

15

Start / End Page

3376 / 3382

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Risk Assessment
  • Recurrence
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Maximum Tolerated Dose
  • Male
  • Leukemia, T-Cell
  • Infusions, Intravenous