Diffuse Large B Cell LymphomaNCT05040555
R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
A study testing R-CDOP in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma Grade 3B, run by oubai, MD/PhD at 1 site in China.
Trial summary
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
- What is being tested?
- R-CDOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2021to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;
- Has at least one evaluable or measurable lesion according to Lugano response criteria;
- Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV >220cm3;
- Patients previously untreated;
- Patients aged over 18 and under 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0~2;
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- International Prognostic Index (IPI) score > 1, or with extranodal mass diameter ≥7cm;
- Life expectancy ≥ 6 months;
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
- Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
Who cannot join
- Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
- Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value) ;
- Absolute Neutrophil Count (ANC)<1.5×10^9/L or Platelet (PLT)< 75 × 10^9/L;
- Hypersensitivity to any study drug or its ingredients;
- Patients with significant and uncontrolled cardiovascular disease or history;
- Persons with mental disorders/unable to obtain informed consent;
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- Lymphoma infiltrates the central nervous system;
- Previous history of malignant tumor;
- HIV infection; HBV infection (HBV-DNA> 2000 IU/ml);HCV infection (HCV-RNA>200 IU/ml);
- The investigator determined not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Ou BAI, doctor, 13039046656, oubai16@163.com
About this study
Official title: A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
Read the detailed description
The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome.
At least 3 nodal sites (each with a diameter greater than 3 cm) ; Nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm) ; Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT Total Metabolic Tumor Volume (TMTV)>220cm3.
- Being tested
- R-CDOP
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CDOPCombination product
Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5.
| Study group | Role | What they receive |
|---|---|---|
| R-CDOP | Experimental | Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5. Receives: Combination Product: R-CDOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
Measured: 24 months
Secondary outcomes (4)
Disease Control Rate
Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014.
Measured: 24 months
Progression-free survival
Progression-free survival（PFS） is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.
Measured: 24 months
Overall survival
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
Measured: 60 months
Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start30 Aug 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- oubai, MD/PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, oubai, MD/PhD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040555
- Sponsor's protocol ID
- CSPC-DMS-NHL-001
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of R-CDOP Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma With High Tumor Burden
- ClinicalTrials.gov ID
- NCT05040555
- Acronym / sponsor ID
- CSPC-DMS-NHL-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- oubai, MD/PhDUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 10 Sep 2021 (actual)
- 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.
A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
Detailed description
The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome.
At least 3 nodal sites (each with a diameter greater than 3 cm) ; Nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm) ; Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT Total Metabolic Tumor Volume (TMTV)>220cm3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CDOP | Experimental | Combination Product: R-CDOPRituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;
- Has at least one evaluable or measurable lesion according to Lugano response criteria;
- Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV >220cm3;
- Patients previously untreated;
- Patients aged over 18 and under 75 years;
Key exclusion criteria (10 listed)
- Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
- Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value) ;
- Absolute Neutrophil Count (ANC)<1.5×10^9/L or Platelet (PLT)< 75 × 10^9/L;
- Hypersensitivity to any study drug or its ingredients;
- Patients with significant and uncontrolled cardiovascular disease or history;
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-CDOPRituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5. | Combination product | R-CDOP |
Primary outcome
Objective response rate
Time frame: 24 months
Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.
4 secondary outcomes
Disease Control Rate
Time frame: 24 months
Progression-free survival
Time frame: 24 months
Overall survival
Time frame: 60 months
Adverse Events
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R-CDOP in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma Grade 3B, run by oubai, MD/PhD at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ou BAI, doctor (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 24 months). 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 16 Sep 2021.