SWOG CTP's First Trial Moves to Protocol Development
SWOG Clinical Trials Partnerships (SWOG CTP) recently signed a contract in support of the first clinical trial to be conducted entirely within CTP – 21CTP.LEUK01. With budget and contract negotiations complete, protocol development and study build are getting underway in earnest.
What does this mean, and how will SWOG CTP studies differ from the many other clinical trials SWOG conducts?
The most basic difference is this: SWOG Cancer Research Network studies are done in conjunction with the National Cancer Institute and are supported, at least in part, by federal funding through the NCI. SWOG CTP trials, by contrast, involve no federal funding – they are supported entirely by our industry partners on the trial and, for regulatory purposes, are sponsored by SWOG.
These trials are jointly designed and conducted with SWOG committees and our industry partners, and it’s important to note that they’re designed not to compete with federally funded trials (though they are designed to be as rigorous and scientifically relevant as our NCI trials).
21CTP.LEUK01 is a phase II trial testing the investigational agent asciminib as part of treatment in patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) who are aged 60 or older or are not candidates for standard intensive chemotherapy.
Dr. Anjali Advani (vice chair of our leukemia committee) is study chair on the trial, with Dr. Michaela Liedtke as co-chair and Dr. Jerald Radich as translational medicine chair. Our lead statistician on the trial is Dr. Megan Othus, and Gail Sperling is the patient advocate advising on the study. The trial is being developed in close collaboration with our leukemia committee, chaired by Dr. Harry Erba. And, of course, overall leadership of the CTP endeavor is by Dr. Kathy Albain, SWOG’s vice chair for clinical trials partnerships.
As I mentioned above, the protocol is now in development and will soon go through a RaPID review call, followed by reviews by our industry collaborator, the CTP executive review committee, the FDA, and our institutional review board (CTP is working with a commercial IRB). We anticipate trial activation in late summer, and we expect to select up to 35 member sites to open the study, which has an accrual goal of 55 patients.
We recently sent a brief survey to lead oncology research professionals at many of our member sites to help us learn more about sites’ standard processes in selecting and launching non-federal studies. The goal is to align our outreach about coming CTP trials as effectively as we can to mesh with site practices and expectations in terms of timing and resources needed.
What can your site expect with 21CTP.LEUK01 and future SWOG CTP trials?
We will reach out to all SWOG member sites in the coming weeks by email, providing you a study synopsis, with a study calendar and funding memo. If the study looks like one your site may be interested in opening, the email will include a link to a feasibility survey for you to complete and submit.
Based on data submitted in that survey, we’ll invite qualifying sites to participate and sign a study contract with SWOG CTP. Once we have a fully executed contract, we’ll work with you on the needed regulatory documentation to prepare your site for activation, and we’ll give you access to the infrastructure systems CTP is using to conduct its trials.
These include a commercial electronic trial master file (eTMF) system that offers much of the same functionality CTSU.org provides for NCI trials. This eTMF will serve as our repository for study protocols and ancillary materials, while the public face of SWOG CTP trials will primarily be the swogctp.org website.
Electronic data capture will be done through Nebula, proprietary software developed by Cancer Research And Biostatistics (CRAB). For CTP trials, Nebula will replace the OPEN, Rave, and CTEP-AERS systems we use on NCI studies.
Some tools will remain the same. The SWOG Specimen Tracking System will be used, for example, as will the SWOG Expectation and Query Reports.
We have other exciting CTP initiatives pending with other companies – many with opportunities for early- and mid-career investigators. Three additional trial concepts have been approved by the executive review committee, and those projects are now in budget and contract negotiations with other industry partners. You’ll hear more about these in the coming weeks and months.
Until then, watch your inbox for an email from SWOG Clinical Trials Partnerships about the 21CTP.LEUK01 trial, and consider joining us on the inaugural study of our SWOG CTP venture.
Our next Best of SWOG webinar is set for Wednesday, January 31, 2 – 3 pm ET / 11 am – 12 pm PT. It will feature five presentations on some of the most significant findings we published or presented in 2023. Here’s the lineup:
- Michelle Y. Zhang, MD – obesity and OS in S1203 patients with AML (ASH 2023)
- Rachna Shroff, MD – S1815 results in patients with advanced biliary tract cancers (ASCO GI 2023)
- Priyanka Sharma, MD – S1416 results in patients with triple-negative breast cancer with “BRCA-like” phenotype (Lancet Oncology)
- Riha Vaidya, PhD – representativeness of Lung-MAP participants (JCO Precision Oncology)
- Robert S. Krouse, MD – results of S1316 trial in malignant bowel obstruction (Lancet Gastroenterology & Hepatology)
Invitations to the event will be in all members’ mailboxes shortly!
CME credit will be offered.