Chłoniak: badanie fazy I/II leku brigatinib

Kryteria włączenia kto może wziąć udział (8)

1. Patients must be ≥ 1 and < 26 years of age at the time of enrollment, and able to swallow brigatinib tablets at the time of enrollment, with a minimum weight of 10 kg.
2. Patients must have a histologically confirmed diagnosis of cancer at baseline. In patients where a repeat biopsy at relapse (or moment of refractory disease) is considered not feasible by the treating physician, archived material from diagnosis needs to be available for central review.
3. 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.
4. Phase 1: • Patients with ALCL must be relapsed/refractory or intolerant to standard therapies. Refractory disease for ALCL is defined as: o no response to at least one course of ALCL99/other standard of care chemotherapy (SD or PD of measurable lesions), and/or o MRD-positivity by qualitative PCR for NPM-ALK after at least one course of ALCL99/other standard of care chemotherapy (before the second course of chemotherapy). • Patients with relapsed/refractory (R/R) IMT must not be suitable for curative surgical resection without causing mutilation. Newly diagnosed patients with locally advanced IMT, for whom surgery may not be feasible for close proximity to vital structures, without prior tumor-shrinkage, may also be included, as well as metastatic disease. • Patients with other solid tumors (excluding IMT) must have relapsed or refractory disease.
5. Phase 2: • Patients with ALCL must be relapsed/refractory. Refractory disease for ALCL is defined as: o no response to at least one course of ALCL99/other standard of care chemotherapy (SD or PD of measurable lesions), and/or o MRD-positivity by qualitative PCR for NPM-ALK after at least one course of ALCL99/other standard of care chemotherapy (before the second course of chemotherapy). • Patients with R/R IMT Relapsed/refractory IMT, or newly diagnosed, including locally advanced and metastatic IMT which cannot be surgically resected without causing mutilation.
6. Performance Status: • Karnofsky performance status ≥40% for patients >16 years of age or Lansky Play Scale ≥40% for patients ≤16 years of age for ALCL patients in phase 2. • Karnofsky performance status ≥50% for patients >16 years of age or Lansky Play Scale ≥50% for patients ≤16 years of age, for IMT and other solid tumors and for ALCL patients in phase 1.
7. Patients must not be receiving other investigational medications (defined as medicinal products not yet approved for any indications, including alternative/herbal therapies) within 30 days of first dose of study drug or while on study.
8. Cohort B1R and B2R: Patients who were previously treated in the phase 1 or phase 2 part of this study, who completed brigatinib treatment as defined in this protocol, who responded to prior brigatinib treatment on protocol, and who developed a relapse or progression within 12 months after completion of brigatinib treatment (defined as per the EOT visit date).