Optimizing early phase clinical trial washout periods: a report from the Therapeutic Advances in Childhood Leukemia and Lymphoma consortium

Author:

Schafer Eric S12ORCID,Rushing Teresa3,Crews Kristine R4,Annesley Colleen5,Colace Susan I67,Kaiser Nicole8,Pommert Lauren910,Ramsey Laura B11,Sabnis Himalee S1213,Wong Kenneth314,Chang Bill H15,Cooper Todd M5,Shah Nirali N16,Rheingold Susan R17,Place Andrew E18,Chi Yueh-Yun314,Bhojwani Deepa314,Wayne Alan S314,Bernhardt M Brooke4

Affiliation:

1. Department of Pediatrics, Baylor College of Medicine , Houston, TX, USA

2. Texas Children’s Cancer and Hematology Center, Texas Children’s Hospital , Houston, TX, USA

3. Cancer and Blood Disease Institute, Children’s Hospital Los Angeles , Los Angeles, CA, USA

4. Department of Pharmacy and Pharmaceutical Sciences, St Jude Children’s Research Hospital , Memphis, TN, USA

5. Seattle Children’s Hospital Cancer and Blood Disorders Service, University of Washington School of Medicine , Seattle, WA, USA

6. Division of Hematology, Oncology and Blood and Marrow Transplant, Nationwide Children’s Hospital , Columbus, OH, USA

7. Department of Pediatrics, the Ohio State University College of Medicine , Columbus, OH, USA

8. Center for Cancer and Blood Disorders, Children’s Hospital Colorado , Aurora, CO, USA

9. Division of Oncology, Cancer and Blood Diseases Institute, Cincinnati Children’s Hospital Medical Center , Cincinnati, OH, USA

10. Department of Pediatrics, University of Cincinnati College of Medicine , Cincinnati, OH, USA

11. Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, Children’s Mercy Kansas City, Department of Pediatrics, University of Missouri , Kansas City, MO, USA

12. Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta , Atlanta, GA, USA

13. Department of Pediatrics, Emory University School of Medicine , Atlanta, GA, USA

14. University of Southern California Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California , Los Angeles, CA, USA

15. Division of Pediatric Hematology Oncology, Oregon Health and Science University , Portland, OR, USA

16. Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA

17. Division of Oncology and Center for Childhood Cancer Research, Children’s Hospital of Philadelphia, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA

18. Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, Harvard Medical School , Boston, MA, USA

Abstract

Abstract Background The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required to utilize evidence- and/or rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance. Methods A TACL task force reviewed the consortium’s research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration to make expert consensus and evidence-based recommendations for modernizing, broadening, and codifying TACL-study washout periods while ensuring consistency with pediatric ethics, and federal regulations. TACL’s screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment. Results Over a 19-year period, 42 (14.6% of all screened ineligible patients [n = 287]) patients were identified as excluded from TACL early phase studies exclusively because of not meeting washout criteria. An additional 6 (2.1%) did not meet washout and at least 1 other exclusion criterion. A new TACL washout guidance document was developed and then adopted for use. Where washout criteria were not eliminated, rationale- and/or evidenced-based criteria were established with citation. Conclusion In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale- and/or evidenced-based washout period standards largely following guidance from the NCI and ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.

Funder

Higgins Family Charitable Foundation

Intramural Research Program

Center of Cancer Research

National Cancer Institute and NIH Clinical Center

National Institutes of Health

National Cancer Institute

Publisher

Oxford University Press (OUP)

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