Actively Recruiting
Phase 2 Study of Olutasidenib with Temozolomide As Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed with High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations
Led by Rigel Pharmaceuticals · Updated on 2025-02-21
60
Participants Needed
18
Research Sites
313 weeks
Total Duration
On this page
Sponsors
R
Rigel Pharmaceuticals
Lead Sponsor
N
Nationwide Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of olutasidenib combined with temozolomide (TMZ) in treating pediatric and young adult patients newly diagnosed with high-grade glioma (HGG) that has an IDH1 mutation. This international, multicenter phase II trial focuses on patients who have completed radiotherapy and aims to determine if this combination can improve progression-free survival compared to matched historical controls. The study also evaluates tumor response, side effects, and how the body processes olutasidenib. Participants receive olutasidenib and temozolomide as maintenance therapy after finishing focal radiotherapy. Treatment includes 13 cycles of olutasidenib plus TMZ, followed by 13 cycles of olutasidenib alone. The study includes three groups based on tumor type and location: Grade 3 astrocytoma, Grade 4 astrocytoma, and IDH1-mutant diffuse intrinsic pontine glioma (DIPG) or tumors in the thalamus or spinal cord. A feasibility phase identifies the suitable dose of olutasidenib in combination with TMZ. During the study, participants undergo regular assessments including scans to measure tumor progression, blood tests to monitor drug levels, and evaluations of side effects and quality of life. Researchers will track progression-free survival up to two years and overall survival up to five years in some groups. The total study duration includes up to 26 treatment cycles and ongoing monitoring to assess long-term outcomes and safety.
CONDITIONS
Brief Title
Study of Olutasidenib and Temozolomide in HGG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 39 years at enrollment
- Newly diagnosed with IDH1-mutant high-grade glioma, including DIPG
- Tumor tissue available from biopsy or resection
- Diagnosis confirmed by central molecular and histopathologic screening
- No metastatic disease
- Karnofsky or Lansky performance score of 50% or higher depending on age
- Completed standard surgery and radiotherapy as specified
- Started radiotherapy within 31 days of diagnosis
- Able to start study treatment within 21 to 35 days after radiotherapy
- Adequate bone marrow, kidney, and liver function
- Informed consent signed by patient or legal representative
You will not qualify if you...
- Pregnant or breast-feeding women
- Patients not using effective contraception if of childbearing potential
- Concurrent use of other investigational drugs or anticancer agents besides temozolomide
- Use of enzyme-inducing anticonvulsants or strong CYP3A4/5 inducers
- Use of medications known to prolong QTc interval
- Receiving therapeutic anticoagulation with warfarin
- Uncontrolled infections
- Inability to comply with study safety monitoring
- Significant malabsorption or absorption-affecting conditions
- History of HIV, hepatitis B or C infection
- Prior or ongoing serious medical or psychiatric conditions affecting safety or study results
- Prior solid organ transplant
- Secondary or radiation-related high-grade glioma
- Metastatic or disseminated high-grade glioma treated with craniospinal irradiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 cycles of 28 days each
Participants receive maintenance therapy with olutasidenib and temozolomide following completion of radiotherapy.
Visits at the start of each cycle and an end of treatment visit
Duration - Up to 60 months
Participants are monitored for progression-free survival, overall survival, and health-related quality of life after treatment completion.
Periodic visits depending on follow-up schedule
Trial Site Locations
Total: 18 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
4
Susan Chi
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
Duke University Health System
Durham, North Carolina, United States, 27708
Not Yet Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Nationwide Children's Hospital
Columbus, Ohio, United States, 43235
Not Yet Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
9
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
10
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
11
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
12
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
13
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Not Yet Recruiting
14
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G1X8
Not Yet Recruiting
15
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A3J1
Not Yet Recruiting
16
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
17
Princess Máxima Center
Utrecht, Netherlands, 3720
Not Yet Recruiting
18
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Not Yet Recruiting
Research Team
J
Jill DeFratis Robinson
V
Vanessa Tan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here