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References — Acute Lymphoblastic Leukemia (ALL) QSP Model

Curated PubMed-linked references underpinning the QSP map, mrgsolve parameters, and clinical endpoints. Grouped by topic; all PMIDs below were individually verified against PubMed (author/journal/year/title match).

1. Epidemiology and classification

  1. Arber DA, Orazi A, Hasserjian R, et al. Blood 2016. The 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia. https://pubmed.ncbi.nlm.nih.gov/27069254/
  2. McNeil DE, Coté TR, Clegg L, Mauer A. Med Pediatr Oncol 2002. SEER update of incidence and trends in pediatric malignancies: acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/12376977/

2. Genetics and cytogenetics

  1. Roberts KG, et al. N Engl J Med 2014. Targetable kinase-activating lesions in Philadelphia chromosome-like acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/25207766/
  2. Weng AP, Ferrando AA, Lee W, et al. Science 2004. Activating mutations of NOTCH1 in human T cell acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/15472075/
  3. Mullighan CG, Miller CB, Radtke I, et al. Nature 2008. BCR-ABL1 lymphoblastic leukaemia is characterized by the deletion of Ikaros. https://pubmed.ncbi.nlm.nih.gov/18408710/
  4. Bhojwani D, Pei D, Sandlund JT, et al. Leukemia 2012. ETV6-RUNX1- positive childhood acute lymphoblastic leukemia: improved outcome with contemporary therapy. https://pubmed.ncbi.nlm.nih.gov/21869842/
  5. El Chaer F, Keng M, Ballen KK. Curr Hematol Malig Rep 2020. MLL- rearranged (KMT2A-rearranged) acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/32350732/
  6. Paulsson K, Johansson B. Genes Chromosomes Cancer 2009. High hyperdiploid childhood acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/19415723/
  7. Holmfeldt L, Wei L, Diaz-Flores E, et al. Nat Genet 2013. The genomic landscape of hypodiploid acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/23334668/

3. Bone-marrow niche, CXCR4-CXCL12, VLA-4 chemoresistance

  1. Juarez J, Dela Pena A, Baraz R, et al. Leukemia 2007. CXCR4 antagonists mobilize childhood acute lymphoblastic leukemia cells into the peripheral blood and inhibit engraftment. https://pubmed.ncbi.nlm.nih.gov/17410186/
  2. Jacamo R, Chen Y, Wang Z, et al. Blood 2014. Reciprocal leukemia- stroma VCAM-1/VLA-4-dependent activation of NF-κB mediates chemoresistance. https://pubmed.ncbi.nlm.nih.gov/24599548/
  3. Berrazouane S, Doucet A, Boisvert M, Barabé F, Aoudjit F. Cancers (Basel) 2021. VLA-4 induces chemoresistance of T-cell acute lymphoblastic leukemia cells via PYK2-mediated drug efflux. https://pubmed.ncbi.nlm.nih.gov/34298726/

4. Glucocorticoid-receptor apoptosis pathway

  1. Ploner C, Schmidt S, Presul E, et al. J Steroid Biochem Mol Biol 2005. Glucocorticoid-induced apoptosis and glucocorticoid resistance in acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/15860257/

5. Vincristine pharmacology and peripheral neuropathy

  1. Crom WR, de Graaf SS, Synold T, et al. J Pediatr 1994. Pharmacokinetics of vincristine in children and adolescents with acute lymphocytic leukemia. https://pubmed.ncbi.nlm.nih.gov/7931891/
  2. Egbelakin A, Ferguson MJ, MacGill EA, et al. Pediatr Blood Cancer 2011. Increased risk of vincristine neurotoxicity associated with low CYP3A5 expression genotype in children with acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/21225912/
  3. Lopez-Lopez E, Gutierrez-Camino A, Astigarraga I, et al. Pharmacogenomics 2016. Vincristine pharmacokinetics pathway and neurotoxicity during early phases of treatment in pediatric acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/27180762/

6. PEG-asparaginase — PK/PD, hypersensitivity, pancreatitis, thrombosis

  1. Avramis VI, Spence SA. J Pediatr Hematol Oncol 2007. Clinical pharmacology of asparaginases in the United States: asparaginase population pharmacokinetic and pharmacodynamic (PK-PD) models (NONMEM) in adult and pediatric ALL patients. https://pubmed.ncbi.nlm.nih.gov/17414566/
  2. August KJ, Miller WP, Dalton A, Shinnick S. J Pediatr Hematol Oncol 2013. Comparison of hypersensitivity reactions to PEG-asparaginase in children after intravenous and intramuscular administration. https://pubmed.ncbi.nlm.nih.gov/23619117/
  3. Raja RA, Schmiegelow K, Frandsen TL. Br J Haematol 2012. Asparaginase-associated pancreatitis in children. https://pubmed.ncbi.nlm.nih.gov/22909259/
  4. Athale UH, Siciliano SA, Crowther M, Barr RD, Chan AKC. Br J Haematol 2005. Thromboembolism in children with acute lymphoblastic leukaemia treated on Dana-Farber Cancer Institute protocols: effect of age and risk stratification of disease. https://pubmed.ncbi.nlm.nih.gov/15953008/

7. Methotrexate — high-dose PK, CNS penetration, leucovorin rescue

  1. Bleyer WA. Cancer 1978. The clinical pharmacology of methotrexate: new applications of an old drug. https://pubmed.ncbi.nlm.nih.gov/342086/
  2. Evans WE, Hutson PR, Stewart CF, et al. Clin Pharmacol Ther 1983. Methotrexate cerebrospinal fluid and serum concentrations after intermediate-dose methotrexate infusion. https://pubmed.ncbi.nlm.nih.gov/6600662/
  3. Ettinger LJ, Chervinsky DS, Freeman AI, Creaven PJ. Cancer 1982. Pharmacokinetics of methotrexate following intravenous and intraventricular administration in acute lymphocytic leukemia and non-Hodgkin's lymphoma. https://pubmed.ncbi.nlm.nih.gov/6956429/

8. 6-Mercaptopurine/thiopurine PK and TPMT/NUDT15 pharmacogenomics

  1. Lennard L, Lilleyman JS, Van Loon J, Weinshilboum RM. Lancet 1990. Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukaemia. https://pubmed.ncbi.nlm.nih.gov/1973780/
  2. Moriyama T, Nishii R, Perez-Andreu V, et al. Nat Genet 2016. NUDT15 polymorphisms alter thiopurine metabolism and hematopoietic toxicity. https://pubmed.ncbi.nlm.nih.gov/26878724/
  3. Relling MV, Schwab M, Whirl-Carrillo M, et al. Clin Pharmacol Ther 2019. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for thiopurine dosing based on TPMT and NUDT15 genotypes: 2018 update. https://pubmed.ncbi.nlm.nih.gov/30447069/

9. Ph+ ALL — TKI trials (imatinib, dasatinib, ponatinib)

  1. Thomas DA, Faderl S, Cortes J, et al. Blood 2004. Treatment of Philadelphia chromosome-positive acute lymphocytic leukemia with hyper-CVAD and imatinib mesylate. https://pubmed.ncbi.nlm.nih.gov/14551133/
  2. Foà R, Bassan R, Vitale A, et al. N Engl J Med 2020. Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults (GIMEMA LAL2116/D-ALBA). https://pubmed.ncbi.nlm.nih.gov/33085860/
  3. Jabbour E, Kantarjian H, Ravandi F, et al. Lancet Oncol 2015. Combination of hyper-CVAD with ponatinib as first-line therapy for patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia: a single-centre, phase 2 study. https://pubmed.ncbi.nlm.nih.gov/26432046/

10. Blinatumomab (CD19×CD3 BiTE)

  1. Kantarjian H, Stein A, Gökbuget N, et al. N Engl J Med 2017. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia (TOWER trial). https://pubmed.ncbi.nlm.nih.gov/28249141/
  2. Zhu M, Wu B, Brandl C, et al. Clin Pharmacokinet 2016. Blinatumomab, a bispecific T-cell engager (BiTE®) for CD19-targeted cancer immunotherapy: clinical pharmacology and its implications. https://pubmed.ncbi.nlm.nih.gov/27209293/

11. Inotuzumab ozogamicin (anti-CD22 ADC)

  1. Kantarjian HM, DeAngelo DJ, Stelljes M, et al. N Engl J Med 2016. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia (INO-VATE ALL trial). https://pubmed.ncbi.nlm.nih.gov/27292104/
  2. Marks DI, Kebriaei P, Stelljes M, et al. Biol Blood Marrow Transplant 2019. Outcomes of allogeneic stem cell transplantation after inotuzumab ozogamicin treatment for relapsed or refractory acute lymphoblastic leukemia. https://pubmed.ncbi.nlm.nih.gov/31039409/

12. CD19 CAR-T cell therapy

  1. Maude SL, Laetsch TW, Buechner J, et al. N Engl J Med 2018. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia (ELIANA trial). https://pubmed.ncbi.nlm.nih.gov/29385370/
  2. Stein AM, Grupp SA, Levine JE, et al. CPT Pharmacometrics Syst Pharmacol 2019. Tisagenlecleucel model-based cellular kinetic analysis of chimeric antigen receptor-T cells. https://pubmed.ncbi.nlm.nih.gov/30848084/

13. CRS/ICANS grading and management

  1. Lee DW, Santomasso BD, Locke FL, et al. Biol Blood Marrow Transplant 2019. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. https://pubmed.ncbi.nlm.nih.gov/30592986/
  2. Le RQ, Li L, Yuan W, et al. Oncologist 2018. FDA approval summary: tocilizumab for treatment of chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome. https://pubmed.ncbi.nlm.nih.gov/29622697/

14. Friberg semi-mechanistic myelosuppression model

  1. Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO. J Clin Oncol 2002. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. https://pubmed.ncbi.nlm.nih.gov/12488418/

15. Key adult/pediatric ALL trial backbones

  1. Larson RA, Dodge RK, Burns CP, et al. Blood 1995. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: Cancer and Leukemia Group B Study 8811. https://pubmed.ncbi.nlm.nih.gov/7718875/
  2. Silverman LB, Stevenson KE, O'Brien JE, et al. Leukemia 2010. Long-term results of Dana-Farber Cancer Institute ALL Consortium protocols for children with newly diagnosed acute lymphoblastic leukemia (1985-2000). https://pubmed.ncbi.nlm.nih.gov/20016537/
  3. Kantarjian HM, O'Brien S, Smith TL, et al. J Clin Oncol 2000. Results of treatment with hyper-CVAD, a dose-intensive regimen, in adult acute lymphocytic leukemia. https://pubmed.ncbi.nlm.nih.gov/10653870/

16. Minimal/measurable residual disease (MRD) as a biomarker

  1. Berry DA, Zhou S, Higley H, et al. JAMA Oncol 2017. Association of minimal residual disease with clinical outcome in pediatric and adult acute lymphoblastic leukemia: a meta-analysis. https://pubmed.ncbi.nlm.nih.gov/28494052/