Chronic myeloid leukemia, pediatric
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Section editor | |
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David Noyd, MD, MPH University of Oklahoma Oklahoma City, OK |
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
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Guidelines
"How I Treat"
- 2019: Hijiya & Suttorp How I treat chronic myeloid leukemia in children and adolescents
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, rounded to the nearest 100 mg
28-day cycle for 13 cycles (1 year)
Dose 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, divided twice per day and rounded to the nearest 100 mg
28-day cycle for 13 cycles (1 year)
Dose 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
- 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 Clinical Trial Registry
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, rounded to the nearest 50 mg dose
28-day cycle for up to 66 cycles
References
- 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 Clinical Trial Registry
- 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, <20 pts in this cohort (RT) |
Gore et al. 2018 (CA180-226) | 2009-2014 | Phase 2 (RT) |
References
- 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 Clinical Trial Registry
- 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 Clinical Trial Registry
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.
References
- 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 Clinical Trial Registry
Nilotinib monotherapy
Regimen
Study | Dates 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.
References
- CAMN107A2120: Hijiya N, Zwaan CM, Rizzari C, FoĆ 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 Clinical Trial Registry