Health Condition 1: C819- Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: gemcitabine,vinorelbine and dexamethasone: gemcitabine 1000 mg per m2, vinorelbine 25 mg per m2 delivered on d1 and d8 of a 3 weekly cycles for 2 cycles. dexamethasone 40 mg per m2 (max
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: Relapsed/ refractory Hodgkin’s Lymphoma having previously received at least 1 line of standard chemotherapy Age 5- 65 years at the time of enrolmemt ECOG performance status 0 to 1 Written informed consent for adults over 18 years of age, and consent from parents/ legal guardian for those below 18 years of age Negative serum pregnancy test Female patients in the reproductive age group MUST AGREE TO use suitable contraception during the course of therapy Patients with relapsed or refractory disease following stem cell transplantation are permitted Acceptable bone marrow and organ function at screening as described below: a. ANC more than 1500 per mic.L (without WBC growth factor support) b. Platelet count more than 75,000 per mic.L; c. Hemoglobin more than 9 g per dL d. Total Bilirubin less than 1.5 x ULN; e. AST (SGOT) less than 3 x ULN (less than 5 × ULN if known liver metastases) f. ALT (SGPT) less than 3 x ULN (less than 5 × ULN if known liver metastases) g. Serum creatinine less than 2 mg/dL or a measured creatinine clearance more than 40 mL/min according to Cockcroft-Gault formula Measurable disease must be present either on physical examination or imaging studies; non- measurable disease alone is not acceptable
Exclusion criteria
Exclusion criteria: f. Human Immunodeficiency Virus (HIV) infection/and or Anti-retroviral therapy and or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study). g. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HbeAg and HBV DNA titers must be negative and patients would be continued on appropariate prophylaxis with antivirasl throughout the duration of the study). h. History of allogeneic transplant i. Patient with known peptic ulcer disease/ history of GI perforation due to peptic ulcer in the past. j. Uncontrolled medical conditions including but not limited to diabetes mellitus and hypertension. k. Pre-existing peripheral neuropathy of > grade 1 l. Relapse within 6 months of autologous transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR)Timepoint: At 6 weeks ( post 2 cycles of therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survivalTimepoint: at study completion;progression free survivalTimepoint: at study completion;toxicityTimepoint: as measured by CTCAE | — |
Countries
India
Contacts
Public ContactPrasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed