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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

Phase 2N = 121

Population
Children and young adults with refractory or recurrent T-cell disease (121 enrolled; 106 assessable for response).
Design
Single-agent phase II study in four strata: stratum 1, at least 25% marrow blasts in first relapse; stratum 2, at least 25% marrow blasts in second or later relapse; stratum 3, positive CSF; stratum 4, extramedullary (non-CNS) relapse. Initial dose 1.2 g/m2 daily for 5 consecutive days every 3 weeks, with two dose de-escalations because of neurotoxicity on this or other studies (final dose levels 650 and 400 mg/m2/day as described in the abstract).
Arms
  • Stratum 1 (experimental): Nelarabine; at least 25% marrow blasts in first relapse
  • Stratum 2 (experimental): Nelarabine; at least 25% marrow blasts in second or later relapse
  • Stratum 3 (experimental): Nelarabine; positive CSF
  • Stratum 4 (experimental): Nelarabine; extramedullary (non-CNS) relapse
People
Berg SL, Children's Oncology Group
Show the numbers
Results reported for 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
EndpointAnalysisStratum 1 / Stratum 2 / Stratum 3 / Stratum 4ControlEffect
CR+PR ratePatients at the final dose levels (abstract: 121 enrolled, 106 assessable for response)Complete plus partial response rate at the final dose levels, by stratumprimaryBerg 200555%—Patient numbers per stratum and the separate complete-response rates are not given in the abstract. Grade 3 or higher neurologic adverse events: 31 episodes in 27 patients (18% of patients).
Results reported for 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
EndpointAnalysisStratum 1 / Stratum 2 / Stratum 3 / Stratum 4ControlEffect
CR+PR ratePatients at the final dose levels (abstract: 121 enrolled, 106 assessable for response)Complete plus partial response rate at the final dose levels, by stratumprimaryBerg 200555%—Patient numbers per stratum and the separate complete-response rates are not given in the abstract. Grade 3 or higher neurologic adverse events: 31 episodes in 27 patients (18% of patients).
Primary publication: 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;23(15):3376-82. PubMedDOI

Appears in

Sources

  1. 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;23(15):3376-82.

    PubMedDOI