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临床试验/CTRI/2020/08/026992
CTRI/2020/08/026992招募中2 期

Efficacy of weekly paclitaxel in combination with daily oral sodium valproate in relapsed and refractory lymphoma patients- A phase II study

Jawaharlal Institute Post Graduate Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Adult patients with relapsed and refractorylymphoma unfit for aggresive chemotherapy
  • ECOG PS less than or equal to 2
  • Patients should have following lab parameters fulfilled within 14 days of enrollment
  • Absolute neutrophil count >=1000/L
  • Platelet count >= 75000/L
  • Adequate hepatic function defined as Total Bilirubin < 5 times upper limit of normal (ULN), Alaninine transaminase(ALT)/Aspartate transaminase(AST) <3 x ULN
  • Serum creatinine < 2.0 mg/dl

排除标准

  • i.Patient unwilling for study
  • ii.Pregnant and breastfeeding women
  • iii.Patients on oral sodium valproate for any other indication.
  • iv.Patients with history of hypersensitivity to valproate or paclitaxel.
  • v.Patients with peripheral neuropathy of grade 2 or more as per NCI CTCAE Ver 5.1
  • vi.Patients of HIV/Hepatitis B/Hepatitis C infection.
  • vii.Patients with CNS disease as part of NHL/HL and lymphoblastic lymphoma(LBL)

研究者

发起方
Jawaharlal Institute Post Graduate Medical Education and Research

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