A study of low intensity chemotherapy in relapsed and refractory lymphoma patients
- Conditions
- Health Condition 1: C817- Other Hodgkin lymphomaHealth Condition 2: C858- Other specified types of non-Hodgkin lymphoma
- Registration Number
- CTRI/2020/08/026992
- Lead Sponsor
- Jawaharlal Institute Post Graduate Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Progression free survival <br/ ><br>Toxicity <br/ ><br>Study association of serum valproate levels and hyperacetylated end product levels with clinical outcomes. <br/ ><br>Timepoint: PFS: 6 months <br/ ><br>Toxicity: at end of each cycle i.e 3 weeks, 6 weeks, 9 weeks and at 6 months <br/ ><br>Valproate levels and hyperacetylated H3 H4 levels at day 4 and day 11 of 1st cycle