To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B LymphomaNCT03045471
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
An observational study of To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma, run by Shanghai Public Health Clinical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
- What is being tested?
- R-EPOCH and R-CHOP
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with AIDS associated CD20+ diffuse large B lymphoma
Who may be able to join
- male or female aged 18-60 years old;
- Confirmed as AIDS patients and treated with HAART;
- Confirmed as CD20+ diffuse large B lymphoma;
- Serum test; negative for HBV, HCV and syphilis;
- 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);
- 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;
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- Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;
- Negative pregnancy test for female;
- 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;
- To be able to understand and sign the Informed Consent Document with legal force.
Who cannot join
- With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
- Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
- Women with pregnant or breastfeeding;
- Any form of primary immunodeficiency;
- Concurrent Systemic steroid therapy;
- History of severe immediate hypersensitivity reaction to any of the agents used in this study;
- History of allogeneic stem cell transplantation.
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
- Being tested
- R-EPOCH, R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-EPOCHDrug
Also called Rituximab,Etoposide,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici
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-CHOPDrug
Also called Rituximab,Prednisolone,Oncovin,Cyclophosphamide,Hydroxydaunorubici
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.
| Study group | Role | What they receive |
|---|---|---|
| R-EPOCH | Not described Receives: Drug: R-EPOCH | |
| R-CHOP | Not described Receives: Drug: R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 3 years
Secondary outcomes (3)
complete response rate
Measured: 3 years
partial response partial response rate
Measured: 3 years
overall response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Mar 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045471
- Sponsor's protocol ID
- ARL-1
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma
- ClinicalTrials.gov ID
- NCT03045471
- Acronym / sponsor ID
- ARL-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-EPOCH | – | Drug: R-EPOCH |
| R-CHOP | – | Drug: R-CHOP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with AIDS associated CD20+ diffuse large B lymphoma
Key inclusion criteria (10 listed)
- male or female aged 18-60 years old;
- Confirmed as AIDS patients and treated with HAART;
- Confirmed as CD20+ diffuse large B lymphoma;
- Serum test; negative for HBV, HCV and syphilis;
- 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);
Key exclusion criteria (7 listed)
- With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
- Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
- Women with pregnant or breastfeeding;
- Any form of primary immunodeficiency;
- Concurrent Systemic steroid therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-EPOCHAlso: Rituximab,Etoposide,Prednisolone,Oncovin,Cyclophosphamide,HydroxydaunorubiciRituximab: 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. | Drug | R-EPOCH |
| R-CHOPAlso: Rituximab,Prednisolone,Oncovin,Cyclophosphamide,HydroxydaunorubiciRituximab: 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. | Drug | R-CHOP |
Primary outcome
progression-free survival
Time frame: 3 years
3 secondary outcomes
complete response rate
Time frame: 3 years
partial response partial response rate
Time frame: 3 years
overall response
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate the Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma, run by Shanghai Public Health Clinical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, PhD (+8618930810088, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.