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Clinical Trials/CTRI/2020/08/026992
CTRI/2020/08/026992
Recruiting
Phase 2

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 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C817- Other Hodgkin lymphomaHealth Condition 2: C858- Other specified types of non-Hodgkin lymphoma

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: C817- Other Hodgkin lymphomaHealth Condition 2: C858- Other specified types of non-Hodgkin lymphoma
Sponsor
Jawaharlal Institute Post Graduate Medical Education and Research
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Jawaharlal Institute Post Graduate Medical Education and Research

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Outcomes

Primary Outcomes

Not specified

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