Back to search results

Lorlatinib for High-Grade Glioma with ALK or ROS1 Fusion

This study is testing lorlatinib, a drug that targets specific genetic changes (ALK or ROS1 fusions) in newly diagnosed high-grade glioma (a type of brain cancer). It includes conditions like diffuse intrinsic pontine glioma (DIPG) and glioblastoma. You may be eligible if you are between 1 and 21 years old and your tumor has an ALK or ROS1 fusion. Researchers want to see how well lorlatinib controls the disease, either alone, with chemotherapy (like BABY-POG or HIT-SKK), or after radiation therapy. They will also track any side effects. The study plans to enroll 15 participants, but its current status is unclear.

Study design
This is a multi-institutional pilot study with an estimated enrollment of 15 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will receive lorlatinib, either alone or with chemotherapy, for varying durations depending on the treatment arm. The study will assess disease control until the end of cycle 2 (each cycle is 28 days) and adverse events for 30 days after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for 30 days following the end of protocol treatment. Disease control will be measured until the end of cycle 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06333899

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Recruiting
EARLY_PHASE1Ages 1–21InterventionalTreatment
Nationwide Children's Hospital
~15 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:LorlatinibLorlatinib with chemotherapy1Lorlatinib with chemotherapy 2Lorlatinib post Radiation

At a glance

Recruiting sites
2 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Control Rate
Measured over Day 1 of treatment until the end of cycle 2 (each cycle is 28 days)
+1 more outcome measured

Conditions

High Grade Glioma
Diffuse Intrinsic Pontine Glioma
Anaplastic Astrocytoma
Infant Type Hemispheric Glioma
Glioblastoma
Glioblastoma Multiforme
WHO Grade III Glioma
WHO Grade IV Glioma
Diffuse Midline Glioma, H3K27-altered

Explore related trials

Diffuse Intrinsic Pontine GliomaMalignant GliomaALK GeneROS1 Gene

Where it's being run

18 sites across 17 states
Ohio2
Colorado1
District of Columbia1
Illinois1
Massachusetts1
North Carolina1
Pennsylvania1
Texas1

Study leadership

  • Hamza Gorsi, MD · STUDY_CHAIR · Children's Hospital of Michigan
  • Susan Chi, MD · STUDY_CHAIR · Dana-Farber Cancer Institute
  • Maryam Fouladi, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Kelsey H Troyer, PhD
[email protected]
16147223284
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients must not have received any prior anti-cancer chemotherapy.

Exclusion

Peripheral absolute neutrophil count (ANC) ≥ 1000/μL
Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Hemoglobin \>8 g/dL (may receive transfusions) 6.2 Adequate Renal Function Defined as:
Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 6.3 Adequate Liver Function Defined as:
Total bilirubin ≤ 2 × institutional upper limit of normal
AST(aspartate aminotransferase)/ALT(alanine transaminase) ≤ 2.5 × institutional upper limit of normal 6.4 Adequate Pulmonary Function Defined as: Pulse oximetry \> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).
Investigational Agents/Drugs: Patients who have previously received or are currently receiving another investigational drug are not eligible.
Anti-cancer Agents: Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible 3. Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection. 4. Patients who have received prior solid organ transplantation are not eligible. 5. Patients must not have malabsorption syndrome or other condition affecting oral absorption. 6. Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to treatment with loraltinib. Moderate inducers of CYP3A4 should be avoided 7. Avoid concomitant use of lorlatinib with certain CYP3A substrates, for which minimal concentration changes may lead to serious therapeutic failures. If concomitant use is unavoidable, increase the CYP3A substrate dosage in accordance with approved product labeling. 8. P-glycoprotein (P-gp) substrates: Lorlatinib is considered a moderate P-gp inducer. Co-administration of lorlatinib with P-gp substrates including but not limited to digoxin should be avoided as the concentration of these drugs may be reduced by lorlatinib. 9. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. 10. Patients with a known personal history of acute or chronic severe psychiatric disorders or current history of suicidal ideation and history of suicide attempt.

What this trial measures

  • Disease Control RateDay 1 of treatment until the end of cycle 2 (each cycle is 28 days)

    To assess the disease control rate (Complete Response \[CR\], Continued Complete Response \[CCR\], Partial Response \[PR\] and Stable Disease \[SD\]) of lorlatinib in young children with newly diagnosed high-grade glioma with ALK or ROS1 fusion after 2 cycles of lorlatinib monotherapy.

  • Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0From Day 1 of protocol treatment through 30 days following end of protocol treatment

    Assess and further characterize the safety and toxicity of lorlatinib in pediatric patients newly diagnosed with HGG with a fusion in ALK or ROS. This will be achieved by calculating the number of participants with, as well as frequency and severity of, lorlatinib-related Adverse Events as assessed by CTCAE v5.0