Health Condition 1: C817- Other Hodgkin lymphoma Health Condition 2: C858- Other specified types of non-Hodgkin lymphoma
Conditions
Interventions
Intervention1: injection paclitaxel and daily oral sodium valproate
: Tab Sodium Valproate 60mg/kg/day orally in 3 divided doses 3 days followed by 15 mg/kg/d in two divided doses from 4th day till ne
Sponsors
Jawaharlal Institute Post Graduate Medical Education and Research
Eligibility
Inclusion 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 Serum creatinine
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Overall response rates (ORR) of weekly paclitaxel and daily oral sodium valproate in patients of relapsed refractory lymphoma.Timepoint: at baseline,9 weeks and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Toxicity Study association of serum valproate levels and hyperacetylated end product levels with clinical outcomes. Timepoint: PFS: 6 months Toxicity: at end of each cycle i.e 3 weeks, 6 weeks, 9 weeks and at 6 months Valproate levels and hyperacetylated H3 H4 levels at day 4 and day 11 of 1st cycle | — |
Countries
India
Contacts
Public ContactRajath Govind
JIPMER
Outcome results
None listed