The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

NCT ID: NCT03045471

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-12-31

Brief Summary

1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma.

Conditions

To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

R-EPOCH

R-EPOCH

Intervention Type: DRUG

Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Etoposide: a topoisomerase inhibitor from the group of epipodofyllotoxins; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.

R-CHOP

R-CHOP

Intervention Type: DRUG

Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.

Interventions

R-EPOCH

Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Etoposide: a topoisomerase inhibitor from the group of epipodofyllotoxins; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.

Intervention Type: DRUG

R-CHOP

Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.

Intervention Type: DRUG

Other Intervention Names

Rituximab,Etoposide,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici; Rituximab,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici

Eligibility Criteria

Inclusion Criteria

1. male or female aged 18-60 years old;

2. Confirmed as AIDS patients and treated with HAART;

3. Confirmed as CD20+ diffuse large B lymphoma;

4. Serum test; negative for HBV, HCV and syphilis;

5. Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3); Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3);

6. Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl;

7. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;

8. Negative pregnancy test for female;

9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment;

10. To be able to understand and sign the Informed Consent Document with legal force.

Exclusion Criteria

1. With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;

2. Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;

3. Women with pregnant or breastfeeding;

4. Any form of primary immunodeficiency;

5. Concurrent Systemic steroid therapy;

6. History of severe immediate hypersensitivity reaction to any of the agents used in this study;

7. History of allogeneic stem cell transplantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hongzhou Lu, PhD

Role: CONTACT

luhongzhou@fudan.edu.cn

+8618930810088

Renfang Zhang, Msc

Role: CONTACT

zhangrenfang@shaphc.org

+8618916051096

Other Identifiers

ARL-1

Identifier Type: -

Identifier Source: org_study_id