Clinical Trials in the time of COVID-19: How we are adapting and ensuring the continuance of research

The following is a message from the Associate Director for Clinical Research, Mitchell Machtay, MD and Deputy Associate Director for Clinical Research, Mikkael Sekeres, MD.

Patients with cancer often turn to clinical trials because their other treatment options are limited. Though there has been a shift in the conduct of clinical activities, treatment trials remain open to enrollment to meet clinical needs. Each clinical trial is different and we have evaluated protocols on a case-by-case basis to assess patient and caregiver burden with respect to the risk of COVID-19 infection. Our top priority remains safety for participants and research staff. Steps we are keeping include:

  • Trials with moderate and low potential of direct benefits to participants may be closed, suspended or converted to all virtual/phone

  • Keep trial participants informed

  • Share best practices with other cancer centers across the country

  • Involve sponsors, the FDA, and IRBs to make multilateral decisions

  • Require extensive and accurate documentation

We are also tracking when clinical trial participants have to withdraw or go off of treatment due to COVID-19. This will allow the cancer center to report in real-time the impacts on studies and participants.

While activities have shifted due to COVID-19, forward movement of cancer clinical research is still a priority. New trials are consistently being developed and evaluated by our Protocol Review and Monitoring Committee. We’d like to highlight a trial by Aziz Nazha, MD, Phase I/II Trial of CPX-351 + Palbociclib in Patients with Acute Myeloid Leukemia, which has had promising results.

Nazha developed a new phase I/II clinical trial to treat acute myeloid leukemia (AML) based on preclinical work done in Babal Jha’s lab at the Cleveland Clinic. The phase I/II trial of the combination of CPX-351 (liposomal cytarabine-daunorubicin) and Palbociclib in patients with acute myeloid leukemia. The phase I part was dose escalation of Palbociclib in combination with standard dose CPX-351 in patients with released/refractory AML. Nine patients were enrolled on the phase I part; the overall response rate based on intention-to-treat analysis was 67%. Currently, the phase II part is open and enrolling patients. Phase II is restricted to patients newly diagnosed with AML.

Finally, we are hosting our first virtual Clinical Research Retreat on Wednesday, May 20, 2020 from 5-7 pm. This retreat is a great opportunity to network digitally, connect and exchange ideas.

Two keynote speakers will be addressing exciting topics in clinical research: Lydia Furman, MD, Chair, University Hospitals Institutional Review Board, will present on Effectively Communicating Informed Consent in Disparate Population. Susan Pereira Ribeiro, PhD, Senior Instructor in Pathology and Case CCC member, will present on the Translational Research Cycle, Bedside to Bench to Bedside.

All clinicians and research staff are encouraged to participate in this virtual learning event.