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

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ClinicalTrials.gov Identifier: NCT03045471
Recruitment Status : Not yet recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hongzhou Lu, Shanghai Public Health Clinical Center

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.

Condition or disease Intervention/treatment
To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma Drug: R-EPOCH Drug: R-CHOP

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/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 Name: 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 Name: Rituximab,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. complete response rate [ Time Frame: 3 years ]
  2. partial response partial response rate [ Time Frame: 3 years ]
  3. overall response [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AIDS associated CD20+ diffuse large B lymphoma
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045471


Contacts
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Contact: Hongzhou Lu, PhD +8618930810088 luhongzhou@fudan.edu.cn
Contact: Renfang Zhang, Msc +8618916051096 zhangrenfang@shaphc.org

Sponsors and Collaborators
Shanghai Public Health Clinical Center

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Responsible Party: Hongzhou Lu, Professor, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT03045471     History of Changes
Other Study ID Numbers: ARL-1
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Antineoplastic Agents, Alkylating
Etoposide
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Antineoplastic Agents
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists