Chronic myeloid leukemia, pediatric

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 David Noyd, MD, MPH
University of Washington
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This page contains studies that were specific to pediatric populations. For the more general CML page, follow this link.

4 regimens on this page
5 variants on this page


Chronic phase, first-line therapy

Imatinib monotherapy [COG AAML0123]

Regimen variant #1, 340 mg/m2 (stratum 1, 2, or 3)

Study Dates of enrollment Evidence
Champagne et al. 2011 (COG AAML0123) 2002-2004 Phase 2 (RT)

Targeted therapy

  • Imatinib (Gleevec) 340 mg/m2 PO once per day on days 1 to 28, rounded to the nearest 100 mg

28-day cycle for 13 cycles (1 year)

Dose and schedule modifications

  • Patient evaluated per protocol after each 28-day cycle for response and toxicities
  • Hold Imatinib (Gleevec) if a grade 2 nonhematologic adverse event fails to resolve or if a grade 3 or 4 nonhematologic adverse event occurs
  • After resolution to < grade 1, Imatinib (Gleevec) dose may be reduced by 30%


Regimen variant #2, 570 mg/m2 (stratum 4)

Study Dates of enrollment Evidence
Champagne et al. 2011 (COG AAML0123) 2002-2004 Phase 2

Targeted therapy

  • Imatinib (Gleevec) 570 mg/m2/day (maximum dose of 1000 mg/day) PO on days 1 to 28, divided twice per day and rounded to the nearest 100 mg

28-day cycle for 13 cycles (1 year)

Dose and schedule modifications

  • Patient evaluated per protocol after each 28-day cycle for response and toxicities
  • Hold Imatinib (Gleevec) if a grade 2 nonhematologic adverse event fails to resolve or if a grade 3 or 4 nonhematologic adverse event occurs
  • After resolution to < grade 1, Imatinib (Gleevec) dose may be reduced by 30%

References

  1. COG AAML0123: Champagne MA, Fu CH, Chang M, Chen H, Gerbing RB, Alonzo TA, Cooley LD, Heerema NA, Oehler V, Wood C, French ME, Arceci RJ, Smith FO, Bernstein ML. Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 15;57(1):56-62. Epub 2011 Apr 4. link to original article link to PMC article contains dosing details in abstract PubMed NCT00030394

Nilotinib monotherapy [COG AAML1321]

Regimen

Study Dates of enrollment Evidence
Hijiya et al. 2019 (DIALOG) 2013-2015 Phase 2 (RT)

Targeted therapy

  • Nilotinib (Tasigna) 230 mg/m2 (maximum dose of 200 mg) PO twice per day on days 1 to 28, rounded to the nearest 50 mg dose

28-day cycle for up to 66 cycles

References

  1. DIALOG: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Aimone P, Allepuz A, Quenet S, Hourcade-Potelleret F, Hertle S, Sosothikul D. Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Blood. 2019 Dec 5;134(23):2036-2045. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01844765
    1. Update: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Patterson B, Samis J, Aimone P, Allepuz A, Titorenko K, Sosothikul D. A phase 2 study of nilotinib in pediatric patients with CML: long-term update on growth retardation and safety. Blood Adv. 2021 Jul 27;5(14):2925-2934. link to original article contains dosing details in manuscript link to PMC article PubMed

Chronic phase, relapsed or refractory

Dasatinib monotherapy

Regimen

Study Dates of enrollment Evidence
Zwaan et al. 2013 (CA180-018) 2006-2009 Phase 1, fewer than 20 pts in this cohort (RT)
Gore et al. 2018 (CA180-226) 2009-2014 Phase 2 (RT)

Targeted therapy

28-day cycles

References

  1. CA180-018: Zwaan CM, Rizzari C, Mechinaud F, Lancaster DL, Lehrnbecher T, van der Velden VH, Beverloo BB, den Boer ML, Pieters R, Reinhardt D, Dworzak M, Rosenberg J, Manos G, Agrawal S, Strauss L, Baruchel A, Kearns PR. Dasatinib in children and adolescents with relapsed or refractory leukemia: results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children with Cancer Consortium. J Clin Oncol. 2013 Jul 1;31(19):2460-8. Epub 2013 May 28. link to original article PubMed NCT00306202
  2. CA180-226: Gore L, Kearns PR, de Martino Lee ML, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. Epub 2018 Mar 2. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00777036

Imatinib monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence
Champagne et al. 2004 (COG P9973) 2000-2001 Phase 1 (RT)

Note: this trial tested a variety of doses; this is the FDA-recommended dose.

Targeted therapy

Continued indefinitely

References

  1. COG P9973: Champagne MA, Capdeville R, Krailo M, Qu W, Peng B, Rosamilia M, Therrien M, Zoellner U, Blaney SM, Bernstein M; Children's Oncology Group phase 1 study. Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study. Blood. 2004 Nov 1;104(9):2655-60. Epub 2004 Jul 1. link to original article contains dosing details in manuscript PubMed NCT00004932

Nilotinib monotherapy

Regimen

Study Dates of enrollment Evidence
Hijiya et al. 2019 (CAMN107A2120) 2011-2015 Phase 1, fewer than 20 pts (RT)

Note: the study enrollment end date is from the sponsor website; it is not mentioned in the manuscript.

Targeted therapy

28-day cycles

References

  1. CAMN107A2120: Hijiya N, Zwaan CM, Rizzari C, Foà R, Abbink F, Lancaster D, Landman-Parker J, Millot F, Moppett J, Nelken B, Putti MC, Tian X, Sinclair K, Santanastasio H, Buchbinder A, Kearns P. Pharmacokinetics of Nilotinib in Pediatric Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia or Acute Lymphoblastic Leukemia. Clin Cancer Res. 2020 Feb 15;26(4):812-820. Epub 2019 Nov 1. link to original article contains dosing details in abstract PubMed NCT01077544
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