Chronic myelogenous leukemia, pediatric

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Wayne H. Liang, MD, MS, FAMIA
Children’s Healthcare of Atlanta/Emory
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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
4 variants on this page


Guidelines

"How I Treat"

COGAAML0123

Stratum 1, 2, or 3

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Regimen

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

Chemotherapy

  • Imatinib (Gleevec) 340 mg/m2 PO rounded to the nearest 100 mg once daily
  • 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%
  • Imatinib (Gleevec) therapy continued until completion of 13 28-day courses (1 year)

28-Day Course


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 protocol PubMed NCT00030394

Stratum 4

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Regimen

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

Chemotherapy

  • Imatinib (Gleevec) 570 mg/m2 PO divided BID rounded to the nearest 100 mg (maximum dose of 1000 mg)
  • 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 the resolution to < grade 1, Imatinib (Gleevec) dose may be reduced by 30%
  • Imatinib (Gleevec) therapy continued until completion of 13 28-day courses (1 year)

28-Day Course

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 protocol PubMed NCT00030394

COGAAML1321

Nilotinib monotherapy

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Regimen

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

Targeted therapy

  • Nilotinib (Tasigna) 230 mg/m2 PO twice per day rounded to the nearest 50 mg dose (maximum dose of 400 mg)

28-Day Course 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 verified protocol 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 verified protocol link to PMC article PubMed

Chronic phase, first-line therapy

Imatinib monotherapy

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Regimen

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

Targeted therapy

28-day cycles

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 protocol PubMed NCT00030394

Nilotinib monotherapy

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Regimen

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

Targeted therapy

Continued indefinitely

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 verified protocol link to PMC article PubMed NCT01844765

Chronic phase, relapsed or refractory

Dasatinib monotherapy

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Regimen

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

Targeted therapy

Continued indefinitely

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 verified protocol PubMed NCT00777036

Imatinib monotherapy

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Regimen

Study Years of enrollment Evidence
Champagne et al. 2004 (COG P9973) 2000-2001 Phase 1 (RT)

Targeted therapy

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 PubMed NCT00004932

Nilotinib monotherapy

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Regimen

Study Years of enrollment Evidence
Hijiya et al. 2019 (CAMN107A2120) 2011-2015 Phase 1, <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 protocol PubMed NCT01077544