Mycosis Fungoides Clinical Trial
Official title:
A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
This is a multi-center, dose-finding, Phase 1 study of pralatrexate plus bexarotene in
patients who have relapsed or refractory CTCL.
Primary Objective(s):
• Determine the maximum tolerated dose (MTD) and recommended dose of pralatrexate plus
bexarotene with concurrent vitamin B12 and folic acid supplementation when administered to
patients who have failed prior systemic treatment.
Secondary Objective(s):
- Determine the safety profile of pralatrexate plus bexarotene when administered to
patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL).
- Collect preliminary efficacy data.
- Determine the pharmacokinetic (PK) profile of pralatrexate plus bexarotene in patients
who underwent plasma PK sampling
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