Actively Recruiting
Study of Olutasidenib and Temozolomide in HGG
Led by Rigel Pharmaceuticals · Updated on 2025-02-21
60
Participants Needed
18
Research Sites
534 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
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
CONDITIONS
Official Title
Study of Olutasidenib and Temozolomide in HGG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 39 years at enrollment
- Newly diagnosed with an IDH1-mutant high-grade glioma including diffuse intrinsic pontine glioma (DIPG)
- Tumor tissue available from biopsy or resection for diagnosis confirmation
- Diagnosis confirmed as WHO Grade 3 or 4 glioma or DIPG with pontine epicenter and diffuse involvement
- No metastatic disease present
- Karnofsky performance score of at least 50% for patients older than 16 years or Lansky score of at least 50 for patients 16 years or younger
- Prior surgery, radiation therapy (standard doses), and dexamethasone allowed
- Temozolomide allowed if given concurrently with radiotherapy and post-radiotherapy maintenance
- Radiation therapy started within 31 days of diagnosis
- Enrollment and treatment start within 21 days post-radiotherapy for pre-maintenance phase patients or within 35 days for others
- Adequate bone marrow function (ANC ≥ 1000/mm3, platelets ≥ 100,000/mm3, hemoglobin > 8 g/dL)
- Adequate renal function (creatinine clearance ≥ 70 ml/min/1.73 m2 or age/gender-based serum creatinine limits)
- Adequate liver function (bilirubin ≤ 1.5× institutional upper limit, AST/ALT < 3× upper limit, alkaline phosphatase < 3× upper limit)
- Signed informed consent from patient or guardian
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unwilling to use highly effective contraception during treatment and for 3 months afterwards
- Current use of another investigational drug
- Use of anti-cancer agents other than temozolomide concurrently with radiotherapy or maintenance
- Use of enzyme-inducing anticonvulsants that strongly induce CYP3A4/5
- Use of strong CYP3A4/5 inducers within 14 days prior to enrollment and during study
- Use of medications known to prolong QTc interval
- Therapeutic anticoagulation with warfarin
- Uncontrolled infections
- Known malabsorption syndrome or conditions affecting drug absorption
- History of HIV, hepatitis B or C infection
- Prior solid organ transplant
- Secondary or radiation-related high-grade glioma
- Metastatic or disseminated high-grade glioma treated with craniospinal irradiation
- Medical or psychiatric conditions preventing safe study participation or assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
V
Vanessa Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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