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Miami Cancer Institute Leads Landmark Phase 2 Glioblastoma Trial

 

Glioblastoma (GBM) remains one of the most devastating diagnoses in oncology with a median survival of just 16 to 18 months following diagnosis. Leading the charge to improve outcomes is Baptist Health Miami Cancer Institute, where physician-investigators are heading a new clinical study for newly diagnosed GBM patients that is researching the benefits of combining ruxolitinib with the current standard-of-care regimen of radiation therapy plus temozolomide.

Manmeet Ahluwalia, M.D.

Manmeet Ahluwalia, M.D

The randomized Phase 2 CRUX-2 trial (Ruxolitinib in Combination with Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma) is currently recruiting.

Introducing CRUX-2: A Promising Approach

“The CRUX-2 trial represents a major academic effort to meaningfully improve survival for patients,” says Manmeet Ahluwalia, M.D., principal investigator. Dr. Ahluwalia holds the Fernandez Family Foundation Endowed Chair in Cancer Research, as well as serving as chief of medical oncology, chief scientific officer and deputy director of the Institute and Baptist Health Cancer Care.

Building on Early-Phase Research

The groundwork for today’s development was laid through early-phase investigational work by Dr. Ahluwalia and his team. He presented results from the initial CRUX trial (NCT03514069) at the 2023 American Society of Clinical Oncology Annual Meeting.

“The study showed that ruxolitinib, a JAK1/JAK2 inhibitor which targets the JAK/STAT pathway associated with tumor progression, was very well tolerated,” he says. “Ruxolitinib with 75 mg/m2 of temozolomide with radiation of 60 Gy over six weeks is safe, feasible and demonstrated positive efficacy among patients with WHO Grade 3-4 newly-diagnosed high-grade gliomas.”

A National Collaboration

The Phase 2 trial will evaluate the efficacy of ruxolitinib when administered with radiation and temozolomide alone. The  national significance of CRUX-2 is underscored by the caliber of institutions collaborating to join Miami Cancer Institute in the effort — Cleveland Clinic, Dartmouth-Hitchcock Medical Center, Fred Hutchingson Cancer Center (in collaboration with the University of Washington), NYU Grossman School of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center.

“Together, we have an opportunity to drive revolutionary change that will improve the quality of our patients’ lives and extend their survival,” Dr. Ahluwalia notes.

To refer a patient or learn more about CRUX-2, contact Dr. Ahluwalia here.

 


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