B-cell acute lymphoblastic leukemia, pediatric, Ph-positive
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David Noyd, MD, MPH University of Washington Seattle, WA, USA |
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.
5 regimens on this page
5 variants on this page
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Guidelines
NCCN
Upfront induction therapy
Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Shen et al. 2020 (CCCG-ALL-2015-Ph) | 2015-2018 | Phase 3 (E-switch-ic) | Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib | Superior EFS48 |
Chemotherapy
Glucocorticoid therapy
Targeted therapy
- Dasatinib (Sprycel) 80 mg/m2/day PO
28-day course
Subsequent treatment
- See paper for details
References
- CCCG-ALL-2015-Ph: 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
- COG AALL1122: NCT01460160
Daunorubicin, Pegaspargase, Vincristine, Prednisone, Imatinib
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Shen et al. 2020 (CCCG-ALL-2015-Ph) | 2015-2018 | Phase 3 (E-switch-ic) | Daunorubicin, Pegaspargase, Vincristine, Prednisone, Dasatinib | Inferior EFS48 |
Chemotherapy
Glucocorticoid therapy
Targeted therapy
- Imatinib (Gleevec) 300 mg/m2/day PO
28-day course
Subsequent treatment
- See paper for details
References
- CCCG-ALL-2015-Ph: 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 | Dates of enrollment | Evidence |
|---|---|---|
| Schultz et al. 2009 (COG AALL0031) | 2002-2006 | Phase 2 (RT) |
Note: the schedule is not specified for etoposide and ifosfamide, and the filgrastim dose is erroneous within the manuscript.
Preceding treatment
- Induction (see paper for details)
Chemotherapy
- Etoposide (Vepesid) 100 mg/m2 IV (schedule not specified)
- Ifosfamide (Ifex) 3400 mg/m2 IV (schedule not specified)
Targeted therapy
- Imatinib (Gleevec) 340 mg/m2 PO once per day
Supportive therapy
- Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 6 to 15
21-day course
Subsequent treatment
- Consolidation block 2 (see paper for details)
References
- 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
- 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 | Dates 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
- 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