OncoMatch/Clinical Trials/NCT04925609
Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors
Is NCT04925609 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Brigatinib for anaplastic large cell lymphoma, alk-positive.
Treatment: Brigatinib — This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Tumor Agnostic
Biomarker criteria
Required: ALK activating aberration
Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to be available for central laboratory confirmation of ALK status. For ALK+ ALCL, detection of ALK with immunohistochemistry (IHC) is sufficient for inclusion, all others require molecular evidence of a ALK fusion gene or mutation by FISH, PCR or NGS. ALK detection will be confirmed centrally with FISH.
Prior therapy
Cannot have received: brigatinib (brigatinib)
Patients who already received previous treatment with ALK inhibitors except for brigatinib can be included in this study.
Lab requirements
Blood counts
ANC ≥0.75 × 10^9/L (except in case of MAS or bone marrow involvement); Platelet count ≥75 × 10^9/L (≥50 × 10^9/L post SCT); Hemoglobin ≥8 g/dL or 5.0 mmol/L (transfusions allowed if no active bleeding or hemolysis)
Kidney function
serum creatinine ≤1.5 x ULN for age OR radioisotope GFR ≥70 mL/min/1.73m2
Liver function
direct bilirubin ≤1.5 x ULN for age AND AST and ALT ≤5 x ULN for age (unless related to involvement of the liver or histiocytic/macrophage inflammatory process)
Cardiac function
shortening fraction ≥27% by echocardiogram OR LVEF ≥50% by MUGA; QTcF ≤450 ms
Patients must meet the organ function and system function requirements as stated below: ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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