Health Professional Resources
Leading health professionals have developed disease specific suggestions for the management of cancer in adolescent and young adult cancer patients during the COVID-19 crisis and treatment protocol suggested modifications
The chemotherapy protocol-specific suggestions herein are for patients who are not on a clinical trial see (Patients on a Clinical Trial below). The aim is to provide a forum for the exchange of information concerning interactions between the evolving COVID-19 pandemic and ALL/LBL therapy and supportive care. They are dependent on the local epidemiology of the COVID-19 infection. We have tried to conduct a substantive review of each item recommended, but we also know that the state of the science during the pandemic is dynamic. It remains the responsibility of the patient’s medical professional to decide on the appropriate medical advice, diagnosis, and treatment for patients. For patients on clinical trials, the Study Chair must be consulted before deviation from the protocol.
During the COVID-19 pandemic, the suggestions will be updated every few days, with the version dated for reference. Check the suggestions frequently in case they have changed.
Also, assist us by identifying information that has been particularly helpful so that we might more prominently feature it, as well as any information that is inaccurate, outdated or inappropriate so that we can remove it. The FAQs pull-down menu on the homepage has a field at the bottom to submit questions and comments.
Patients on Clinical Trials
According to the CIRB NCI directives issued in response to the COVID-19 pandemic, changes in the clinical trials protocol require Study Chair approval, who may modify the protocol only at the trial-wide level with review and approval by the CIRB in the form of an official amendment prior to implementation. The same Guidance also states that actions under emergent circumstances are not considered Serious and/or Continuing Noncompliance actions. If a deviation occurs, it and the reason(s) for it should be documented in the patient’s record, including how the deviation was explained to the patient and that his/her consent was obtained. Regardless, according to the NCI directives, Study Chair should be informed about the deviation in order to be able to assess the benefit and risk of the modification and ultimately improve the clinical trial from lessons learned.
The incidence of documented COVID-19 infection in Wuhan, China was directly proportional to age above 10,with the rate 3-4x greater in 10-19 year-olds and 20x greater in 20-39 year-olds than in 1-9 year-olds (Fig. 1 ). Two deaths were in AYAs with ALL, who were 14 and 31 years of age. Wuhan investigators also reported that six 1-7 year-old, previously healthy children had uneventful recovery after 5-13 days hospitalization.
As of April 2, 17% of 12,550 COVID-19 patients who died in Italy had a diagnosis of cancer during the previous 5 years. Only 35 were <40 years of age and 6 were <30 years (youngest 24 years). No data were provided on the pre-existing morbidities of AYAs.
As of April 2, 2,572 Americans <18 years of age were known by the CDC to be diagnosed with COVID-19. Of these cases, 32% occurred in adolescents aged 15–17 years, followed 27% of those aged 10–14 years (Fig. 2 ). Among 745 with known hospitalization status, infants had a higher rate of hospitalization, but 42% more 10-17 year-olds were diagnosed to be infected than <10 year-olds and they had higher rate of ICU admissions (Fig. 2 ). Immuno-suppression was the 3rd most common pre-existing condition, after heart and lung disease. The cause of immunosuppression was not provided.
1. Frequently Asked Questions Regarding COVID-19 and The CIRB.
2. FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic: Guidance for Industry, Investigators, and Institutional Review Boards.
3. Pan A, Liu L, Wang C, et al. JAMA. Published online April 10, 2020. doi:10.1001/jama.2020.6130
4. Liu W, Yu H, Liu Y, et al. Detection of Covid-19 in children in early January 2020 in Wuhan, China. NEJM 382(Apr 2);14:1370-1.
5. Palmieri L, Andrianou X, Barbariol P, et al. Characteristics of COVID-19 patients dying in Italy. Report based on available data.
6. Coronavirus Disease 2019 in Children — United States, February 12–April 2, 2020. MMWR Morb Mortal Wkly Rep. ePub: 6 April 2020.http://dx.doi.org/10.15585/mmwr.mm6914e4external icon.