Diffuse Large B-cell LymphomaNCT05784987
R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A study testing Rituximab, Mitoxantrone hydrochloride liposome and Isophosphamide in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab, Mitoxantrone hydrochloride liposome and Isophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 1 Jan 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Join the study voluntarily and sign the informed consent;
- Age ≤ 18 years old ≤75 years old;
- Expected survival time ≥3 months;
- Recurrent or refractory diffuse large B-cell lymphoma confirmed by histopathology;
- Consistent with relapsed or refractory lymphoma: Relapsed lymphoma refers to lymphoma that relapsed after CR obtained from initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor shrinkage < 50% or progression after 4 courses of chemotherapy prescribed by the standard regimen; 2) CR was achieved by standard chemotherapy, but recurrent within half a year; 3) Relapse for two or more times after CR; 4) Recurrence after hematopoietic stem cell transplantation;
- There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be > 1.0cm;
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- ECOG score 0-2;
- Bone marrow function: neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×10^9/L, platelet count ≥50×10^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement);
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion);
Who cannot join
- The subject's previous history of antitumor therapy meets one of the following conditions:
- Previous recipients of mitoxantrone or mitoxantrone liposomes;
- Prior treatment with doxorubicin or anthracycline with a cumulative dose of doxorubicin > 360 mg/m2 (1 mg of doxorubicin for other anthracyclines);
- Patients who had received autologous hematopoietic stem cell transplantation or had received allogeneic hematopoietic stem cell transplantation within 100 days of the first medication;
- Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking anti-tumor active Chinese medicine, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the drug in this study;
- Hypersensitivity to any investigational drug or its components;
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- Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
- Cardiac function and disease conform to one of the following conditions:
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block;
- severe, uncontrolled arrhythmias requiring medical treatment;
- New York College of Cardiology Grade ≥ III;
- A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to recruitment.
- Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies /mL; HCV RNA over 1x10^3 copies /mL);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Past or present co-existing malignancies (in addition to non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years);
- Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma at the time of recruitment;
- There is significant gastrointestinal disease at the time of screening that may affect drug intake, transport or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Pregnant and lactating women and patients of childbearing age who do not wish to take contraceptive measures;
- Situations in which other researchers have determined that participation in this study is not appropriate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Read the detailed description
Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. At present, there are no studies on the efficacy and safety of R-MINE+X regimen based on molecular typing in the treatment of R/R DLBCL. Therefore, based on NGS, R/R DLBCL was divided into different molecular types (MCD subtype, BN2 subtype, EZB subtype, A53 subtype and other subtype), and on this basis, different molecular types of targeted drugs (X: MCD/BN2 subtype - BTK inhibitor, EZB subtype - Chidamide, A53 subtype - PD-1 monoclonal antibody and other type - lenalidomide) were used to treat R/R DLBCL. The main purpose was to observe the effectiveness and safety of the program in R/R DLBCL.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Rituximab, Mitoxantrone hydrochloride liposome, Isophosphamide, Etoposide, X: Orelabrutinib
- Keywords
- DLBCL, R-MINE+X, Mitoxantrone liposome
- 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.
RituximabDrug
375 mg/m2, d0, Cycle 1~4
Mitoxantrone hydrochloride liposomeDrug
20 mg/m2, d1, Cycle 1~4
IsophosphamideDrug
1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1~4
EtoposideDrug
65 mg/m2, d1-3, Cycle 1~4
X: OrelabrutinibDrug
MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2~4
X: ChidamideDrug
EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2~4
X: PenpulimabDrug
TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2~4
X: LenalidomideDrug
Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2~4
| Study group | Role | What they receive |
|---|---|---|
| R-MINE+X | Experimental | R-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide
X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide Receives: Drug: Rituximab; Drug: Mitoxantrone hydrochloride liposome; Drug: Isophosphamide; Drug: Etoposide; Drug: X: Orelabrutinib; Drug: X: Chidamide; Drug: X: Penpulimab; Drug: X: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy
Measured: up to 4 cycles of chemotherapy(each cycle is 21 days)
Secondary outcomes (5)
Complete remission rate(CRR)
Complete remission rate(CRR) after 4 cycles of R-MINE+X chemotherapy
Measured: up to 4 cycles of chemotherapy(each cycle is 21 days)
Duration of remission(DOR)
Time from reaching CR or PR for the first time to disease progression
Measured: up to 4 cycles of chemotherapy(each cycle is 21 days)
Progression-Free-Survival rate
from date of inclusion to date of progression, relapse, or death from any cause
Measured: 1 year
Overall survival rate
from the date of inclusion to date of death, irrespective of cause
Measured: 1 year
Adverse events (AE)
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard
Measured: From the first day of medication to 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 posted27 Mar 2023
- Study start15 Apr 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xu, PhD& MD, Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784987
- Sponsor's protocol ID
- CSPC-DED-DLBCL-K09
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang JH, Zhang XY, Bi LT, Qin WW, Su LP, Liu JB, Wu JZ, Yin H, Kong YL, Shen HR, Li JY, Li Y, Wang L, Xu W. R-MINE-containing regimen in relapsed and refractory diffuse large B-cell lymphoma: a single-arm, multicenter phase II study. BMC Med. 2026 Jul 9. doi: 10.1186/s12916-026-05051-z. Online ahead of print.
PubMed 42426809
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT05784987
- Acronym / sponsor ID
- CSPC-DED-DLBCL-K09
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL, R-MINE+X, Mitoxantrone liposome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Mar 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.
Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Detailed description
Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. At present, there are no studies on the efficacy and safety of R-MINE+X regimen based on molecular typing in the treatment of R/R DLBCL. Therefore, based on NGS, R/R DLBCL was divided into different molecular types (MCD subtype, BN2 subtype, EZB subtype, A53 subtype and other subtype), and on this basis, different molecular types of targeted drugs (X: MCD/BN2 subtype - BTK inhibitor, EZB subtype - Chidamide, A53 subtype - PD-1 monoclonal antibody and other type - lenalidomide) were used to treat R/R DLBCL. The main purpose was to observe the effectiveness and safety of the program in R/R DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-MINE+X | Experimental | Drug: Rituximab, Drug: Mitoxantrone hydrochloride liposome, Drug: Isophosphamide, Drug: Etoposide, Drug: X: Orelabrutinib, Drug: X: Chidamide, Drug: X: Penpulimab, Drug: X: LenalidomideR-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Join the study voluntarily and sign the informed consent;
- Age ≤ 18 years old ≤75 years old;
- Expected survival time ≥3 months;
- Recurrent or refractory diffuse large B-cell lymphoma confirmed by histopathology;
- Consistent with relapsed or refractory lymphoma: Relapsed lymphoma refers to lymphoma that relapsed after CR obtained from initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor shrinkage < 50% or progression after 4 courses of chemotherapy prescribed by the standard regimen; 2) CR was achieved by standard chemotherapy, but recurrent within half a year; 3) Relapse for two or more times after CR; 4) Recurrence after hematopoietic stem cell transplantation;
Key exclusion criteria (20 listed)
- The subject's previous history of antitumor therapy meets one of the following conditions:
- Hypersensitivity to any investigational drug or its components;
- Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
- Cardiac function and disease conform to one of the following conditions:
- Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies /mL; HCV RNA over 1x10^3 copies /mL);
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 |
|---|---|---|
| Rituximab375 mg/m2, d0, Cycle 1~4 | Drug | R-MINE+X |
| Mitoxantrone hydrochloride liposome20 mg/m2, d1, Cycle 1~4 | Drug | R-MINE+X |
| Isophosphamide1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1~4 | Drug | R-MINE+X |
| Etoposide65 mg/m2, d1-3, Cycle 1~4 | Drug | R-MINE+X |
| X: OrelabrutinibMCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2~4 | Drug | R-MINE+X |
| X: ChidamideEZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2~4 | Drug | R-MINE+X |
| X: PenpulimabTP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2~4 | Drug | R-MINE+X |
| X: LenalidomideOther-X: Lenalidomide: 25mg/d, d1-10, Cycle 2~4 | Drug | R-MINE+X |
Primary outcome
Objective Response Rate(ORR)
Time frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy
5 secondary outcomes
Complete remission rate(CRR)
Time frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
Duration of remission(DOR)
Time frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
Progression-Free-Survival rate
Time frame: 1 year
Overall survival rate
Time frame: 1 year
Adverse events (AE)
Time frame: From the first day of medication to 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 27 Mar 2023.
- Derived from this study: PubMed 42426809Liang JH, Zhang XY, Bi LT, Qin WW, Su LP, Liu JB, Wu JZ, Yin H, Kong YL, Shen HR, Li JY, Li Y, Wang L, Xu W. R-MINE-containing regimen in relapsed and refractory diffuse large B-cell lymphoma: a single-arm, multicenter phase II study. BMC Med. 2026 Jul 9. doi: 10.1186/s12916-026-05051-z. Online ahead of print.
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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.
Wei Xu, PhD& MD principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab, Mitoxantrone hydrochloride liposome and Isophosphamide in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 9 inclusion and 20 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 27 Mar 2023. 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 Jinhua Liang, M.D (15952032421, 1151525490@qq.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: up to 4 cycles of chemotherapy(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?
On the ClinicalTrials.gov record for NCT05784987, which also lists 1 linked publication.
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 27 Mar 2023.