Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Nivolumab, Doxorubicin, Vinblastine, Dacarbazine: Low dose Nivolumab 40 mg IV plus AVD regimen Doxorubicin 25 mg per m2 IV Vinblastine 6 mg per m2 IV Dacarbazine 375 mg per m2 IV on Day
Sponsors
Tata Memorial Centre
Lady Tata Memorial Trust
Eligibility
Inclusion criteria
Inclusion criteria: Age 15 to 60 years ECOG performance status 0 to 2 Advanced stage Hodgkin lymphoma Lugano stage III and IV disease or stage II with adverse features such as bulky mediastinum bulky node more than 10 cm in diameter or extranodal disease Adequate hematopoietic reserve Platelet count more than 100000 per mm3 Neutrophil count more than 1500 per mm3 Patients with cytopenias due to bone marrow involvement or HLH may be included Adequate organ function Creatinine clearance more than 60 ml per min per 1.73 m2 BSA using Cockcroft Gault equation AST and ALT less than 2.5 times upper limit of normal unless due to disease involvement Total bilirubin less than 3 mg per dL or less than twice upper limit of normal unless due to Gilbert syndrome or disease No history of or active interstitial pneumonitis or interstitial lung disease No requirement of systemic corticosteroids more than 10 mg daily prednisone equivalent or other immunosuppressive drugs within 14 days prior to registration Inhaled or topical steroids are allowed No active autoimmune disease requiring systemic treatment in the past 2 years Adequate cardiac function with left ventricular ejection fraction more than 50 percent Life expectancy more than 3 months Women of childbearing potential must use effective contraception Willing to comply with study follow up Written informed consent obtained
Exclusion criteria
Exclusion criteria: Presence of active uncontrolled infection Cardiac comorbidities such as decompensated cardiac failure coronary artery disease uncontrolled arrhythmias or uncontrolled hypertension Uncontrolled diabetes mellitus History of malignancy except adequately treated skin malignancy such as basal cell carcinoma or squamous cell carcinoma or in situ cervical carcinoma within the last 10 years Other malignancies are allowed if disease free for more than 3 years History of prior treatment for Hodgkin lymphoma except use of corticosteroids for up to one week Known HIV positive status Central nervous system involvement by lymphoma Medical or psychiatric illness that may interfere with compliance or ability to provide informed consent Hodgkin lymphoma as part of composite lymphoma Known intolerance or hypersensitivity to any study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival defined as time from start of treatment to disease progression or deathTimepoint: Assessed up to 12 months from initiation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival defined from date of PET 2 scan after 2 cycles ABVD to first progression relapse need for non protocol radiation need for alternate chemotherapy or death due to Hodgkin lymphoma Timepoint: Assessed up to 12 months or last follow up;Overall survival defined from date of PET 2 scan to death due to any cause or last known aliveTimepoint: Assessed up to 12 months or last follow up;Incidence of acute and late toxicities as per CTCAE version 5Timepoint: During treatment and up to 30 days after last dose and during follow up | — |
Countries
India
Contacts
Public ContactDr Lingaraj Nayak
Tata Memorial Hospital
Outcome results
None listed