A study in HIV infected blood cancer patients to know to test two types of chemotherapy regimen. Patients will be divided in two equal groups for testing purpose.
- Conditions
- Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma
- Registration Number
- CTRI/2020/10/028220
- Lead Sponsor
- Tata Memorial Hospital Research Administrative Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with histologically proven AIDS related diffuse large B cell lymphoma (excluding Burkittââ?¬•s or Burkittââ?¬•s-like lymphomas) with or without CNS involvement
2. No prior chemotherapy for lymphoma
3. Absolute CD4 count >50/�µL.
4. Age- 15-65 years
5. ECOG Performance status <4
6. Adequate organ function
7. Written informed consent
8. Able to comply with the study protocol- absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
1.Presence of other co-morbidities (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cerebrovascular event in last 6 months, myocardial infarction within last 6 months, uncontrolled arrhythmias, congestive heart failure, other conditions) which can result in poor tolerance to therapy in investigators opinion.
2. Ongoing uncontrolled infections
3. Primary CNS lymphoma
4. Pregnancy
5. Patients on anti-tubercular therapy or other enzyme inducer drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Complete Response RateTimepoint: 1. At the end of 2 cycles (2 months) and at the end of 6 cycles (6 months).
- Secondary Outcome Measures
Name Time Method 1. Time to the attainment of a complete response. <br/ ><br>2. Pharmacokinetic parameters such as in responders and non-responders. <br/ ><br>3. Incidence of grade 3/4 toxicities <br/ ><br>4. 2-year event-free survival <br/ ><br>5. 2-year overall-free survival <br/ ><br>6. Time to Immune recovery (CD4 count) <br/ ><br>7. Incremental cost effectiveness ratio of the two regimens at the end of two cycle and at the end of two years. <br/ ><br>8. PK parametersTimepoint: 1) Completion of therapy <br/ ><br>2) At the end of therapy <br/ ><br>3) Weekly <br/ ><br>4) 2 year <br/ ><br>5) 2 year <br/ ><br>6) At 4 months, 8 months, 12 months. <br/ ><br>7) At the end of two months, At the end of two months <br/ ><br>8) Day 1 and Day 8