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Patients with Down syndrome can be included in early phase clinical trials- a report from the T2016-003 Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) study

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Fig. 1: Change in methylation after epigenetic treatment.

Data availability

De-identified participant data that support the findings of this article will be shared upon approved written request at 2 years after this article publication, for 7 years from the publication date. These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to TACL Consortium Central Inbox: (Attention: TACL Consortium Administrative Director, Erika Shin-Kashiyama, JD) and will be reviewed by TACL Steering & Prioritization Committee. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.


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We thank the patients and families who participated in this study. We also acknowledge the TACL Consortium’s scientific contribution to and participation in this study, including participating member institutions, investigators, research teams, and the TACL Operations Center. This trial was supported by partial funding from Higgins Charitable Foundation (DB), Bear Necessities, Pediatric Cancer Foundation (MJB), Children’s Cancer Research Fund (CCRF) (MJB), Midwest Athletes Against Childhood Cancer (MACC) Fund (MJB), The Medical College of Wisconsin Cancer Center—Advancing Healthier Wisconsin Partnership Program (MJB), and the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number T32HL007209 (LP).

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NG, DB, MJB, and KRR developed the initial intent of the letter and contributed to the outline. NG, ESS, KRR, and LP completed primary manuscript preparation. All authors contributed to the drafting and revision of the letter and provided final approval to submit the paper for publication.

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Correspondence to N. Gossai.

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Gossai, N., Bhojwani, D., Schafer, E.S. et al. Patients with Down syndrome can be included in early phase clinical trials- a report from the T2016-003 Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) study. Leukemia 37, 1138–1140 (2023).

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