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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03045471
• Other study ID #: ARL-1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 6, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2017
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, PhD
• Phone: +8618930810088
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		3 years
Secondary	complete response rate		3 years
Secondary	partial response partial response rate		3 years
Secondary	overall response		3 years