Effect of Cyclophosphamide given in split doses over 3 days in patients with newly diagnosed diffuse large B cell lymphoma
Not Applicable
- Conditions
- Health Condition 1: C833- Diffuse large B-cell lymphoma
- Registration Number
- CTRI/2019/07/020236
- Lead Sponsor
- Dr Gaurav Prakash
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of complete remission rates and overall response rates after 6 courses of therapy between 2 groupsTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Compare the adverse events profile between the 2 groupsTimepoint: 6 months;Comparison of event free survival in between the 2 groupsTimepoint: 2 years