Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma (NCT03719898) | Clinical Trial Compass
WithdrawnPhase 2
Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma
Stopped: Slow accrual
United States0Started 2018-12-06
Plain-language summary
FDA approved drugs to treat patients with relapsed or refractory anaplastic large cell lymphoma (ALCL) has a median progression free survival of 20 months. Majority of patients relapse in 2 years. This study will evaluate overall response rate of next generation ALK inhibitor brigatinib in ALK positive ALCL patients by overcoming mechanisms of resistance to ALK inhibitors on cancer patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have a histologically confirmed diagnosis of relapsed or refractory ALCL with documented ALK+ status
✓. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIL 2017 criteria as described in detail in section 11.0
✓. Ongoing toxicities from prior therapy must be resolved to ≤ grade 1 (with the exceptions of grade 2 peripheral neuropathy and/or alopecia). Patients with existing toxicities that are non-significant even though greater than grade 1 can be enrolled after discussion with the sponsor-investigator.
✓. Age \> 18 years.
✓. ECOG performance status 0-2
✓. Prior use of ALK inhibitors aside from brigatinib is permitted but 8 patients enrolled need to be ALK inhibitor treatment naive
✓. Patients with no archival tissue available must be agreeable to fresh biopsy at baseline.
✓. Patients with a known history of HIV are permitted provided the CD4 count ≥ 100 cells/µL and serum HIV viral load \< 50 copies/mL. Patients must be on stable combination antiretroviral therapy at the time of treatment initiation.
Exclusion criteria
✕. History of another active primary malignancy within 2 years of initiating study treatment with the exception of non-melanomatous skin cancer, or any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment.
. Patients who have received chemotherapy or radiation therapy within 2 weeks of initiating study treatment.
✕. Patients may not be receiving any other investigational agents.
✕. Patients who have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
✕. History of allergic reactions attributed to other ALK inhibitors
✕. History of interstitial pneumonitis or drug-related pneumonitis
✕. Impaired gastrointestinal function that may affect oral absorption of brigatinib
✕. Patients with known active Hepatitis B or Hepatitis C (defined as having a detectable hepatitis B or C viral load)