SWOG CTP Opens Its First Trial: Is LEUK01 Right for Your Site?
When SWOG Cancer Research Network established its SWOG Clinical Trials Partnerships, our goal was to build a structure for collaborating with industry partners to conduct cancer clinical trials using no federal funding. Each trial would be supported entirely by our industry partner on the trial, and for regulatory purposes, each trial would be sponsored by SWOG. It's a means of expanding our clinical trial portfolio in settings where federal funding was already stretched too thin.
That vision is bearing fruit with the activation of the first of these CTP trials – LEUK01 (NCT06773936).
Developed under CTP’s first Preferred Partnership Program master agreement (read more about that here), 21CTP.LEUK01 is a phase II trial of asciminib, dasatinib, prednisone, and blinatumomab in patients newly diagnosed with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. It will enroll patients with Ph+ ALL who are age 60 or older or who are otherwise not candidates for standard intensive chemotherapy.
The study’s primary endpoint is major molecular remission at day 85 of treatment, but the trial is also assessing survival, toxicities, the duration of remission, and more. It has important translational medicine objectives as well, looking at genetic differences and molecular pathways associated with response to therapy. The enrollment target is 55 participants.
Dr. Anjali Advani (vice chair of our leukemia committee) is LEUK01’s study chair, with Dr. Michaela Liedtke as co-chair, Dr. Jerald Radich as translational medicine chair, Dr. Megan Othus as lead statistician, and Gail Sperling as the patient advocate advisor on the study.
The LEUK01 study protocol has earned institutional review board (IRB) approval (CTP works with a commercial IRB) and Food and Drug Administration approval, and the pieces are now in place for selected sites to complete their regulatory documentation and site agreement so they can start enrolling patients.
A handful of SWOG sites have already applied to open LEUK01, and SWOG CTP has selected several of them to participate, but more sites are needed. If your site may be interested, visit the study web page to learn more, and complete the feasibility survey linked there to apply.
Sites selected to participate will receive a welcome packet with the IRB-approved protocol and other trial documents, along with a study-specific site agreement to complete and return.
Once SWOG CTP has your fully executed site agreement, staff will work with you to complete the needed regulatory documentation, and you’ll get access to (and training on) our trial support systems.
CTP has deployed its own infrastructure to manage LEUK01 and future trials, including a commercial electronic master file system for study documents and a separate electronic data capture system.
As detailed in the funding memo on the LEUK01 web page, SWOG CTP will provide funds specifically to support the site startup activities mentioned above – one activation payment when your site has completed the items on the pre-activation checklist and a second when your site gets IRB approval to enroll to the study. Study funding will flow directly from CTP as trial sponsor.
As if news of CTP’s first active trial wasn’t enough, I can also say that its next trial is barreling toward activation, expected by fall.
21CTP.HN01, the CAPT-HN trial, is a phase II study combining amivantamab, carboplatin, and paclitaxel to treat patients with unresectable locally recurrent or metastatic head and neck squamous cell carcinoma who have been previously treated with a PD-1 or PD-L1 inhibitor.
This study is chaired by Dr. Paul Swiecicki, with Dr. Cristina Rodriguez as co-chair, Dr. J. Chad Brenner as TM chair, Dr. Megan Othus as lead statistician, and Marcia Horn as patient advocate advisor. CTP’s executive review committee has approved the HN01 protocol, which has just gone for FDA review.
A third CTP trial is now moving to protocol development – 21CTP.BREAST01, the MONITOR trial. This will be a phase II platform trial using circulating tumor DNA to monitor treatment response in patients with HR-positive, HER2-negative metastatic breast cancer.
As HN01 (CAPT-HN) and BREAST01 (MONITOR) approach launch, we’ll repeat the activation steps seen with LEUK01, emailing trial information, including a study synopsis and funding memo, to all SWOG site PIs and lead ORPs. That message will feature a link to a feasibility questionnaire interested sites can complete. Sites selected to participate in a trial will complete a study-specific contract with CTP. We’ve got a cheat sheet for this trial activation process.
Visit the LEUK01 trial page on the SWOG CTP website to learn more about this inaugural CTP study and to apply to open it. For even more details on all three CTP trials – and the activation process – check out this slide deck from the CTP Update Forum held at the spring group meeting.
Ramping CTP up to full production mode has required an enormous amount of work. I want to thank, in addition to the trial teams mentioned above, Dr. Kathy Albain for her leadership as SWOG’s vice chair of Clinical Trials Partnerships, and our CTP staff for the countless hours they’ve invested. Judging by the high quality of this first product release (LEUK01), the enterprise has an amazingly bright future.
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