Diffuse Large B-cell LymphomaNCT05990985
The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
A study testing Mitoxantrone hydrochloride liposome injection, RiTUXimab Injection and Cyclophosphamid in people with Diffuse Large B-cell Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Mitoxantrone hydrochloride liposome injection, RiTUXimab Injection and Cyclophosphamid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age≥18 years old
- International Prognostic Index (IPI)>2
- Expected survival ≥ 3 months
- DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype
- Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment
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- At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion: Greatest transverse diameter>1.5cm; Extra-nodal lesion: Greatest transverse diameter>1.0cm
- ECOG Performance Status: 0-1
- Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group)
- Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases).
Who cannot join
- Hypersensitivity to any study drug or its components
- Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
- Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac ejection fraction (LVEF)< 45%
- Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal)
- Human immunodeficiency virus (HIV) infection (HIV antibody positive)
- Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years)
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- Subjects suffering from primary or secondary central nervous system (CNS) lymphoma
- pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures
- Mental patients or those who cannot obtain informed consent
- Unsuitable subjects for this study determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, PHD, 13039046656, oubai16@163.com
About this study
Official title: A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Mitoxantrone hydrochloride liposome injection, RiTUXimab Injection, Cyclophosphamid, Vincristine, Prednisolone
- 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.
Mitoxantrone hydrochloride liposome injectionDrug
Also called duoenda
Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
RiTUXimab InjectionDrug
Also called lituoxidankang
RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
CyclophosphamidDrug
Also called huanlinxianan
Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
VincristineDrug
Also called changchunxinjian
Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
PrednisoloneDrug
Also called ponisong
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| RCMOP | Experimental | RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment Receives: Drug: Mitoxantrone hydrochloride liposome injection; Drug: RiTUXimab Injection; Drug: Cyclophosphamid; Drug: Vincristine; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Measured: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
Secondary outcomes (5)
Complete response rate (CRR)
To evaluate the efficacy of anti-tumor
Measured: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Measured: CR or PR up to data cut-off (up to approximately 2 years)
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Measured: Baseline up to data cut-off (up to approximately 2 years)
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Measured: Baseline up to data cut-off (up to approximately 2 years)
Treatment emergent adverse events (TEAEs)
The incidence and severity of adverse events assessed by CTCAE v5.0
Measured: The first dose up to 21 or 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2026 (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.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990985
- Sponsor's protocol ID
- CSPC-DED-DLBCL-K10
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
- ClinicalTrials.gov ID
- NCT05990985
- Acronym / sponsor ID
- CSPC-DED-DLBCL-K10
- Conditions
- Diffuse Large B-cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 14 Aug 2023 (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 clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCMOP | Experimental | Drug: Mitoxantrone hydrochloride liposome injection, Drug: RiTUXimab Injection, Drug: Cyclophosphamid, Drug: Vincristine, Drug: PrednisoloneRiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age≥18 years old
- International Prognostic Index (IPI)>2
- Expected survival ≥ 3 months
- DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype
Key exclusion criteria (10 listed)
- Hypersensitivity to any study drug or its components
- Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
- Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac ejection fraction (LVEF)< 45%
- Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal)
- Human immunodeficiency virus (HIV) infection (HIV antibody positive)
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 |
|---|---|---|
| Mitoxantrone hydrochloride liposome injectionAlso: duoendaMitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. | Drug | RCMOP |
| RiTUXimab InjectionAlso: lituoxidankangRiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle. | Drug | RCMOP |
| CyclophosphamidAlso: huanlinxiananCyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. | Drug | RCMOP |
| VincristineAlso: changchunxinjianVincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. | Drug | RCMOP |
| PrednisoloneAlso: ponisongPrednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle. | Drug | RCMOP |
Primary outcome
Objective response rate (ORR)
Time frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
To evaluate the efficacy of anti-tumor
5 secondary outcomes
Complete response rate (CRR)
Time frame: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
Duration of Response (DOR)
Time frame: CR or PR up to data cut-off (up to approximately 2 years)
Progression-free survival (PFS)
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival (OS)
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Treatment emergent adverse events (TEAEs)
Time frame: The first dose up to 21 or 28 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoxantrone hydrochloride liposome injection, RiTUXimab Injection and Cyclophosphamid in people with Diffuse Large B-cell Lymphoma, run by The First Hospital of Jilin University 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ou Bai, PHD (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 (ORR) (time frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)). 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 18 Aug 2023.