SWOG CTP Is Coming of Age

At the opening of our current but now almost done NCTN grant cycle (early 2019), I appointed Dr. Kathy Albain vice chair of SWOG Clinical Trials Partnerships, an expanded initiative for conducting industry-funded clinical trials, with special attention to preferred industry collaborations. 

In the closing weeks of this NCTN grant cycle, then, it seems appropriate to take stock of what SWOG CTP has accomplished. 

In a word: much!

2025 saw the activation of the first two clinical trials developed within SWOG CTP. 

The first is the Leuk01 (21CTP.LEUK01) study in acute lymphoblastic leukemia. Five SWOG member sites have been greenlighted to enroll to this trial thus far, and we should enroll our first patient shortly. Place your bets on which of these five will take the honor: 

• University of California – Irvine
• Baptist Clinical Research Institute (Memphis, TN, with two affiliates in Mississippi)
• Duke University Hospital
• University of Cincinnati Medical Center
• R.J. Zuckerberg Cancer Center/Northwell Health (Lake Success, Long Island, NY)

Four other sites have trial agreements executed and will be greenlighted soon for Leuk01, and another dozen sites are on their way.

The second SWOG CTP trial activated is the CAPT-HN Trial (21CTP.HN01), a phase II study in head-and-neck squamous cell carcinoma. Our first member site in line should be greenlighted to enroll to it within a matter of days 

Other exciting trials are in the CTP development pipeline. 

• CTP’s second leukemia committee study, the Leuk02 trial in cytopenic myelofibrosis, is sailing along on an expedited timeline, with a spring activation expected (more on this below). 
• Development of the Breast01 MONITOR protocol has progressed nicely. 
• CTP’s first transplant committee trial (BMT01) is in the early stages of development.

Several other study proposals are now in negotiation with industry partners.

With the launch of SWOG CTP’s first two trials, we’ve fielded lots of questions from sites about the CTP activation process. To help get you started, here’s a cheat sheet on the process. 

When possible, at each stage of trial development and activation, we’ve tried to highlight CTP parallels to the terminology, steps, and resources members are familiar with from our NCI-supported trials.

So here are translations of some key terms from SWOG NCI to SWOG CTP:

• concept or capsule  →  synopsis
• triage  →  feasibility go/no-go
• CTEP steering cmte concept review  →  executive review cmte (ERC) synopsis review
• CTEP study review  →  ERC study review
• Medidata RAVE  →  CRAB Nebula

The most fundamental difference between our NCTN and NCORP trials on the one hand and SWOG CTP trials on the other is federal funding – it provides key support for trials in the first group, while it’s entirely absent in the second, as CTP trials are fully covered  by industry partners.

Another key difference is that while development of an NCI-supported trial, from initial capsule to trial activation, can require a 2- to 4-year timeline, time from feasibility review to activation within CTP is typically considerably shorter.

All CTP study development is on an expedited timeline, including our second leukemia trial. Feasibility review was conducted in early August 2025, we completed ERC study review (the equivalent of CTEP study review) a few weeks ago.  We expect to submit the study for IRB review in early April and activate it soon thereafter. As we all know, delays can happen, but we’re confident that Leuk02’s launch cycle will move it from idea (study introduction) to activated trial in under a year. That’s expedited. 

While we’re accelerating trial development, we’re also working to streamline and improve trial conduct – especially the member site experience in opening CTP trials. To succeed, we need to hear from CTP sites – ranging from those already greenlighted to those just engaging in the process. What have been your challenges and successes? How can we do it better? 

Come tell us in San Francisco. At SWOG’s spring group meeting, the CTP team will host a round table at the ORP Open Forum session, scheduled for Friday, May 1st, 11:00 am – 12:30 pm PT. You’ll be able to pose your questions and offer your ideas to the CTP team directly across the table (in-person only). You can also reach out directly to ctp@swog.org. 

And don’t miss the spring meeting’s SWOG CTP Update Forum, at which the above trials will be discussed in more detail. That session will take place Thursday, April 30th, 5:30 – 6:30 pm PT, and will be accessible both in-person and virtually. 

Speaking of the spring meeting, group meeting season is about to shift into high gear – registration opens next Tuesday, February 24th, for our April 30 – May 2 meeting in San Francisco. Watch for an email, or visit the website next week to learn more and to register. It promises to be a memorable event.