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.

A phase II randomized study to evaluate the efficacy of short-course RR CVEP regimen against short course EPOCH-RR in adolescent and adult seropositive Diffuse large B cell lymphoma.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028220

Enrollment

Registered

2020-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma

Interventions

Intervention1: Rituximab: Two doses of Rituximab in 3 cycles of CVEP. Control Intervention1: RR EPOCH: Two doses of Rituximab in EPOCH in three cycles.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven AIDS related diffuse large B cell lymphoma (excluding BurkittÃ¢â?¬•s or BurkittÃ¢â?¬•s-like lymphomas) with or without CNS involvement 2. No prior chemotherapy for lymphoma 3. Absolute CD4 count >50/Ã?ÂµL. 4. Age- 15-65 years 5. ECOG Performance status 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Complete Response RateTimepoint: 1. At the end of 2 cycles (2 months) and at the end of 6 cycles (6 months).	—

Secondary

Measure	Time frame
1. Time to the attainment of a complete response. 2. Pharmacokinetic parameters such as in responders and non-responders. 3. Incidence of grade 3/4 toxicities 4. 2-year event-free survival 5. 2-year overall-free survival 6. Time to Immune recovery (CD4 count) 7. Incremental cost effectiveness ratio of the two regimens at the end of two cycle and at the end of two years. 8. PK parametersTimepoint: 1) Completion of therapy 2) At the end of therapy 3) Weekly 4) 2 year 5) 2 year 6) At 4 months, 8 months, 12 months. 7) At the end of two months, At the end of two months 8) Day 1 and Day 8	—

Measure

Time frame

1. Time to the attainment of a complete response. 2. Pharmacokinetic parameters such as in responders and non-responders. 3. Incidence of grade 3/4 toxicities 4. 2-year event-free survival 5. 2-year overall-free survival 6. Time to Immune recovery (CD4 count) 7. Incremental cost effectiveness ratio of the two regimens at the end of two cycle and at the end of two years. 8. PK parametersTimepoint: 1) Completion of therapy 2) At the end of therapy 3) Weekly 4) 2 year 5) 2 year 6) At 4 months, 8 months, 12 months. 7) At the end of two months, At the end of two months 8) Day 1 and Day 8

—

Countries

India

Contacts

Public ContactDr Manju Sengar

Tata Memorial Centre

manju.sengar@gmail.com02224177211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026