B-cell acute lymphoblastic leukemia, pediatric, Ph-positive

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David Noyd, MD, MPH
University of Oklahoma
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This page contains studies that were specific to pediatric populations. For the more general pediatric B-ALL page, follow this link. For the more general Ph+ B-ALL page, follow this link.

4 regimens on this page
4 variants on this page


Guidelines

NCCN

Upfront induction therapy

Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Shen et al. 2020 (CCCG-ALL-2015) 2015-2018 Phase 3 (E-switch-ic) Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib Superior EFS48

Chemotherapy

Glucocorticoid therapy

Targeted therapy

28-day course

Subsequent treatment

  • See paper for details

References

  1. CCCG-ALL-2015: Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. link to original article link to PMC article PubMed ChiCTR-IPR-14005706
  2. COG AALL1122: NCT01460160

Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Shen et al. 2020 (CCCG-ALL-2015) 2015-2018 Phase 3 (E-switch-ic) Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib Inferior EFS48

Chemotherapy

Glucocorticoid therapy

Targeted therapy

28-day course

Subsequent treatment

  • See paper for details

References

  1. CCCG-ALL-2015: Shen S, Chen X, Cai J, Yu J, Gao J, Hu S, Zhai X, Liang C, Ju X, Jiang H, Jin R, Wu X, Wang N, Tian X, Pan K, Jiang H, Sun L, Fang Y, Li CK, Hu Q, Yang M, Zhu Y, Zhang H, Li C, Pei D, Jeha S, Yang JJ, Cheng C, Tang J, Zhu X, Pui CH. Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):358-366. Epub 2020 Jan 16. link to original article link to PMC article PubMed ChiCTR-IPR-14005706

Consolidation after upfront therapy (including post-remission therapy)

Note that many of these regimens are complex and as such will be referred to by their study name, not by the individual drug names. This is also a phase of treatment often referred to as post-remission or postinduction therapy.

Etoposide, Ifosfamide, Imatinib

Regimen

Study Years of enrollment Evidence
Schultz et al. 2009 (COG AALL0031) 2002-2006 Phase 2 (RT)

Chemotherapy

Targeted therapy

References

  1. COG AALL0031: Schultz KR, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Wang C, Davies SM, Gaynon PS, Trigg M, Rutledge R, Burden L, Jorstad D, Carroll A, Heerema NA, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a Children's Oncology Group study. J Clin Oncol. 2009 Nov 1;27(31):5175-81. Epub 2009 Oct 5. link to original article link to PMC article PubMed NCT00022737
    1. Update: Schultz KR, Carroll A, Heerema NA, Bowman WP, Aledo A, Slayton WB, Sather H, Devidas M, Zheng HW, Davies SM, Gaynon PS, Trigg M, Rutledge R, Jorstad D, Winick N, Borowitz MJ, Hunger SP, Carroll WL, Camitta B; Children’s Oncology Group. Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group study AALL0031. Leukemia. 2014 Jul;28(7):1467-71. Epub 2014 Jan 20. link to original article link to PMC article PubMed

Imatinib-based consolidation

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Biondi et al. 2012 (EsPhALL) 2004-2009 Phase 3 (E-esc) No imatinib in consolidation Did not meet primary endpoint of DFS481

1This regimen did not meet the primary efficacy endpoint in the ITT population, but there was a possible signal in the as-treated population.
See paper for details beyond "IB". To be completed (?)

Preceding treatment

  • Berlin–Frankfurt–Munster high-risk backbone

Chemotherapy

Targeted therapy

CNS therapy, prophylaxis

References

  1. EsPhALL: Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. Epub 2012 Aug 14. link to original article link to PMC article PubMed NCT00287105