Health Condition 1: C833- Diffuse large B-cell lymphoma
Conditions
Interventions
Intervention1: Fractionated Cyclophosphamide: Rituximab @375mg/m2 on Day 1
Doxorubicin @ 50mg/m2 on Day 1
Vincristine 1.4mg/m2 on Day 1
Prednisolone @60mg/m2 from Day 1-5
Cyclophosphamide 500mg/m2 iv
Sponsors
Dr Gaurav Prakash
Dr Charanpreet Singh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed DLBCL with any of the following characteristics a. ABC phenotype on IHC according to Hans Protocol b. IPI ranging from 2-5 c. Bulky baseline disease with at least one node/mass measuring >7.5cm d. More than one extra nodal site involvement e. Stage III/IV 2. Able to understand and provide an informed consent 3. ECOG performance status must be less than or equal to 2 at the time of randomisation
Exclusion criteria
Exclusion criteria: 1. Active infection with hepatitis b/hepatitis c/HIV 2. Documented CNS disease 3. History of another lymphoma in the past which might have transformed to DLBCL 4. History of hematuria in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of complete remission rates and overall response rates after 6 courses of therapy between 2 groupsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the adverse events profile between the 2 groupsTimepoint: 6 months;Comparison of event free survival in between the 2 groupsTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactCharanpreet Singh
PGIMER, Chandigarh
Outcome results
None listed