Less restrictive enrollment criteria warranted for MDS clinical trials

Key clinical point: Less restrictive inclusion and exclusion criteria are warranted to improve the participation of patients with myelodysplastic syndrome (MDS) in clinical trials.

Major finding: Each trial was suitable for ~18% of patients in the cohort, whereas 34% of the patients were eligible for at least 1 of the 9 trials. Pharma-initiated trials excluded more than twice the fraction of patients vs. investigator-initiated trials (inclusion, 10% vs. 21%). Key reasons for exclusion included karyotype (average exclusion rate, 58%), comorbidities (40%), and previous therapies (55%)

Study details: A simulation exercise was performed to estimate the average proportion of MDS patients eligible for participation in a clinical trial. A total of 1,809 patients were included in the cohort.

Disclosures: This study did not receive any funding. K Nachtkamp, T Schroeder, E Schuler, J Kaivers, A Giagounidis, C Rautenberg, N Gattermann, and U Germing reported relationships with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Nachtkamp K et al. Leuk Res. 2021 May 11. doi: 10.1016/j.leukres.2021.106611.

Key clinical point: Less restrictive inclusion and exclusion criteria are warranted to improve the participation of patients with myelodysplastic syndrome (MDS) in clinical trials.

Major finding: Each trial was suitable for ~18% of patients in the cohort, whereas 34% of the patients were eligible for at least 1 of the 9 trials. Pharma-initiated trials excluded more than twice the fraction of patients vs. investigator-initiated trials (inclusion, 10% vs. 21%). Key reasons for exclusion included karyotype (average exclusion rate, 58%), comorbidities (40%), and previous therapies (55%)

Study details: A simulation exercise was performed to estimate the average proportion of MDS patients eligible for participation in a clinical trial. A total of 1,809 patients were included in the cohort.

Disclosures: This study did not receive any funding. K Nachtkamp, T Schroeder, E Schuler, J Kaivers, A Giagounidis, C Rautenberg, N Gattermann, and U Germing reported relationships with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Nachtkamp K et al. Leuk Res. 2021 May 11. doi: 10.1016/j.leukres.2021.106611.

Key clinical point: Less restrictive inclusion and exclusion criteria are warranted to improve the participation of patients with myelodysplastic syndrome (MDS) in clinical trials.

Major finding: Each trial was suitable for ~18% of patients in the cohort, whereas 34% of the patients were eligible for at least 1 of the 9 trials. Pharma-initiated trials excluded more than twice the fraction of patients vs. investigator-initiated trials (inclusion, 10% vs. 21%). Key reasons for exclusion included karyotype (average exclusion rate, 58%), comorbidities (40%), and previous therapies (55%)

Study details: A simulation exercise was performed to estimate the average proportion of MDS patients eligible for participation in a clinical trial. A total of 1,809 patients were included in the cohort.

Disclosures: This study did not receive any funding. K Nachtkamp, T Schroeder, E Schuler, J Kaivers, A Giagounidis, C Rautenberg, N Gattermann, and U Germing reported relationships with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Nachtkamp K et al. Leuk Res. 2021 May 11. doi: 10.1016/j.leukres.2021.106611.