Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion (NCT06333899) | Clinical Trial Compass
RecruitingEarly Phase 1
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
United States15 participantsStarted 2025-08-03
Plain-language summary
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion criteria
✓. Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.
✓. Diagnosis:
✓. Disease Status:
✓. Performance Level:
✓. Prior Therapy:
Exclusion criteria
✕. Organ Function Requirements 6.1 Adequate Bone Marrow Function Defined as:
✕.5Adequate Cardiac Function Defined as: QTc ≤ 470 msec (by Bazett formula) 6.6 Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
✕.7 Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
✕. Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
✕. Concomitant Medications
✕. Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.
✕
What they're measuring
1
Disease Control Rate
Timeframe: Day 1 of treatment until the end of cycle 2 (each cycle is 28 days)
2
Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0
Timeframe: From Day 1 of protocol treatment through 30 days following end of protocol treatment