Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia
2018 · paper · Clinical trials
A global phase 2 study of tisagenlecleucel CAR T-cell therapy in 75 evaluable children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia. The overall remission rate was 81%, with 12-month overall survival of 76% and transient high-grade toxic effects.
1 finding
Wording "Tisagenlecleucel transgene was detected in peripheral blood by means of qualitative polymerase chain reaction", but the same paragraph reports Tmax and a geometric-mean AUC "expressed as copies per microgram of DNA times days", which need a quantitative assay.
- p. 5 Results, Tisagenlecleucel Expansion and Persistence, first sentence
Tisagenlecleucel transgene was detected in peripheral blood by means of qualitative polymerase chain reaction.
- p. 5 Same paragraph
(expressed as copies per microgram of DNA times days), was 315,000 in patients with a
- p. 5 Tisagenlecleucel expansion and persistence
qualitative polymerase chain reaction
- p. 5 Tisagenlecleucel Expansion and Persistence
detected in peripheral blood by means of qualitative polymerase chain reaction
Judge's note: Page 5 image checked. The paragraph that this sentence introduces gives copy-number AUC values (315,000 and 301,000) and Tmax. These are quantitative measures, so "qualitative" appears to be a wrong word for "quantitative".
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Wording Discussion: "with only 9% of patients proceeding to undergo allogeneic transplantation". Results report 8 transplanted patients, which is 11% of the 75 infused or 13% of the 61 responders; only the 92 enrolled patients give 9%.
- p. 8 Discussion, end of paragraph comparing with other CAR T products
with only 9% of patients proceeding to undergo allogeneic transplantation
- p. 5 Results, Efficacy
Eight patients underwent allogeneic hematopoietic stem-cell transplantation while in remission
- p. 15 Figure 2 legend
8 patients for allogeneic stem-cell transplantation during remission
Only the authors can say what is right here.
Judge's note: Checked page 8 and the Results on page 5 ("Eight patients underwent allogeneic hematopoietic stem-cell transplantation while in remission"). The sentence does not name its denominator. The surrounding statistics (persistence, relapse-free survival) refer to infused patients or responders, and 9% matches only the enrolled denominator of 92. The authors should state which denominator was used.
Second check: another model agreed
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Wording Table 3 lists "Cytopenia not resolved by day 28" as 28 (37) any grade, 12 (16) grade 3 and 12 (16) grade 4, while the text reports grade 3 or 4 unresolved cytopenias at day 28 in "31 of 75 patients (41%)" (platelets) and "40 of 75 patients (53%)" (neutrophils).
- p. 18 Table 3, Cytopenia not resolved by day 28
28 (37)
- p. 7 Safety, neutrophil count
reported in 40 of 75 patients (53%)
- p. 7 Safety, platelet count
31 of 75 patients (41%) had grade 3 or 4 decreased platelet counts that had not resolved by day 28
Only the authors can say what is right here.
Judge's note: Checked Table 3 on page 18 and the text on page 7. Table 3 gives 24 patients with grade 3–4 events (28 at any grade), fewer than either text count. A count across both cell lines cannot be smaller than either one. The text may come from laboratory values and the table from adverse-event reporting, but neither the paper nor the Table 3 footnote says so. The authors should explain the difference in definition or source.
Second check: another model agreed
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Typo Reference 9 title reads "complete responses (CR) in adult and pediatric and patients with relapsed/refractory" with a stray "and".
- p. 11 Reference 9
adult and pediatric and patients
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: whether the original ASH 2016 abstract title itself contains the duplicated "and". The page image shows the duplicated word as quoted. If the source title has it, the citation reproduces it faithfully.
Second check: none (judge only)