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

Sponsor
Shanghai Public Health Clinical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03045471
Collaborator
(none)
50
Enrollment
58
Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
Anticipated Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
R-EPOCH

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.
Other Names:
  • Rituximab,Etoposide,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici
  • R-CHOP

    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.
    Other Names:
  • Rituximab,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici
  • Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [3 years]

    Secondary Outcome Measures

    1. complete response rate [3 years]

    2. partial response partial response rate [3 years]

    3. overall response [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Public Health Clinical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hongzhou Lu, Professor, Shanghai Public Health Clinical Center
    ClinicalTrials.gov Identifier:
    NCT03045471
    Other Study ID Numbers:
    • ARL-1
    First Posted:
    Feb 7, 2017
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2017