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DLBCL - Diffuse Large B Cell LymphomaNCT07389356

Modified R-MINE Regimen vs. R-GemOx Regimens on the Treatment of Late Relapsed DLBCL

A study testing Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide and Rituximab+Gemcitabine+Oxaliplatin in people with DLBCL - Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study was a multicenter, open, randomized controlled, phase II clinical study. Is expected in 70 cases of late relapsed diffuse large B cell lymphoma, were randomly assigned to receive mitoxantrone liposomes modified R - MINE plan or R - GemOx treatment. Each cycle was 3 weeks (21 days) for a total of 4 cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL - Diffuse Large B Cell Lymphoma
What is being tested?
Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide and Rituximab+Gemcitabine+Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
25 Feb 2026to 30 Dec 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • They voluntarily participated in the study and signed the informed consent.
  • Age 18 or higher;
  • Expected survival time for 3 months or more;
  • The histopathological diagnosed late relapsed (> 12 months) diffuse large B cell lymphoma;
  • Must have at least a Lugano 2014 standard can be evaluation or measurable lesions: lymph node lesions, measurable lymph nodes should be diameter > 1.5 cm; Non-lymph node lesions, measurable extranodal lesions should be diameter > 1.0 cm;
  • ECOG score 0 to 2 points;
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  • Bone marrow function: neutrophil count >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L, and hemoglobin >= 80 g/L (neutrophil count may be extended to >= 1.0 x 10^9 / L, the platelet count can be extended to >= 50 x 10^9 / L, and hemoglobin can be extended to >= 75 g/L in patients with bone marrow involvement);
  • Liver and kidney function: serum creatinine acuities were <= 1.5 times the upper limit of normal (ULN) value; AST and ALT <= 2.5 times the ULN(<= 5 times the upper limit of normal in patients with liver invasion); Total bilirubin <= 1.5 times the ULN (<= 3 times the upper limit of normal in patients with liver invasion);
  • Blood coagulation function: International standardization Ratio (International Normalized thewire, INR) <= 1.5 x ULN; Prothrombin Time (PT), Activated PartialThromboplastin Time (APTT) <= 1.5×ULN (unless receiving anticoagulant therapy, And PT and APTT at screening were within the expected range for anticoagulant therapy).

Who cannot join

  • Previous history of antitumor therapy meeting any of the following conditions:
  • Prior treatment with mitoxantrone or liposomal mitoxantrone;
  • Prior treatment with doxorubicin or other anthracyclines, with a total cumulative doxorubicin dose >360 mg/m² (for other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin);
  • Prior autologous hematopoietic stem cell transplantation within 100 days before the first dose, or a history of allogeneic hematopoietic stem cell transplantation;
  • Prior antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with antitumor activity, etc.) or participation in other clinical trials involving investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug.
  • Hypersensitivity to any study drug or its components;
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  • Uncontrolled systemic diseases (e.g., progressive infections, uncontrolled hypertension, diabetes, etc.);
  • Cardiac function and diseases meeting any 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 fascicular block, type II second-degree or third-degree atrioventricular block;
  • Severe, uncontrolled arrhythmia requiring medication;
  • New York Heart Association Class ≥ III;
  • History of acute myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment within 6 months before enrollment; history of clinically significant pericardial disease; or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
  • Active hepatitis B or C infection (hepatitis B surface antigen positive with HBV DNA >1×10³ copies/mL; HCV RNA >1×10³ copies/mL);
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive);
  • History or concurrent presence of other malignancies (except for effectively controlled non-melanoma skin basal cell carcinoma, in situ carcinoma of the breast/cervix, and other malignancies effectively controlled without treatment in the past five years);
  • Presence of primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at enrollment;
  • Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
  • Requirement for systemic corticosteroid therapy or other immunosuppressive therapy due to a medical condition within 14 days before the start of study treatment [topical use (ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption) is permitted; short-term (≤7 days) corticosteroid use for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) is permitted];
  • Other conditions deemed by the investigator to be unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wei Xu contact

025-68306034

xuwei10000@hotmail.com

About this study

Official title: Rituximab, Ifosfamide, Mitoxantrone Liposome, Etoposide (Modified R-MINE) Regimen vs. Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) Regimen in the Treatment of Late Relapsed Diffuse Large B-cell Lymphoma: A Multicenter, Open, Randomized, Controlled, Phase II Study

This study was a multicenter, open, randomized controlled, phase II clinical study. Is expected in 70 cases of late relapsed diffuse large B cell lymphoma, were randomly assigned to receive mitoxantrone liposomes modified R - MINE plan or R - GemOx treatment. Each cycle was 3 weeks (21 days) for a total of 4 cycles. Subjects assigned to each signed informed consent to screening, screening, in the center of the study determined in accordance with the order signed informed consent. Before the start of the trial, the number of random seeds was set by the statistician, and the block randomization method was used to generate the subject random table using R 4.3.3 (or above). The random ratio between the modified R-mine group and the R-Gemox group was 1:1. After the investigator determined that the subjects were screened successfully, the subjects were randomly numbered according to the order in which the eligible subjects were screened successfully. The intervention was performed by the principal investigator or by someone designated by the principal investigator. Study includes screening period (the first 28 days), treatment period (plan 4 cycles, treatment after 2 cycles enhanced CT/MRI or PET - CT mid-term efficacy, PET - CT curative effect evaluation) after treatment, follow-up (follow-up curative effect, safety and survival follow-up follow-up). Participants provided written informed consent and underwent baseline examinations during the screening period. Participants who met the inclusion criteria and none of the exclusion criteria entered the treatment period. All the study participants completed protocol-specified examinations during the course of treatment to observe efficacy and safety. The end of the treatment period was followed by the follow-up period.

Being tested
Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide, Rituximab+Gemcitabine+Oxaliplatin
Keywords
DLBCL, Mitoxantrone Hydrochloride liposomal
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+EtoposideDrug

    Rituximab 375 mg/m^2, d0; Ifosfamide 1.33 g/m^2, d1-3 (equal dose of mesna rescue); Mitoxantrone hydrochloride liposome 12mg/m^2, d1; Etoposide 65 mg/m^2, d1-3; Every 21 days as one cycle, and 4 cycles were planned.

  • Rituximab+Gemcitabine+OxaliplatinDrug

    Rituximab 375 mg/m^2, d0; Gemcitabine 1000 mg/m^2, d1; Oxaliplatin 100 mg/m^2, d1; Every 21 days as one cycle, and 4 cycles were planned.

Study groups in NCT07389356
Study groupRoleWhat they receive
modified R-MINEExperimentalNot described
Receives: Drug: Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide
R-GemOxActive comparatorNot described
Receives: Drug: Rituximab+Gemcitabine+Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate (CRR)

    Response is assessed according to the lugano criteria.

    Measured: every 2 cycles, up to 4 cycles (each cycle is 21 days)

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Response is assessed according to the lugano criteria.

    Measured: every 2 cycles, up to 4 cycles (each cycle is 21 days)

  2. Duration of response (DoR)

    The time from the first assessment of CR or PR for the tumor to the first assessment of recurrence or PD or death from any cause.

    Measured: 2 years

  3. Progression-free survival (PFS)

    PFS was defined as the time between randomization and the first date of progression, relapse, or death from any cause.

    Measured: 2 years

  4. Overall survival (OS)

    From the date of randomization to date of death, irrespective of cause.

    Measured: 2 years

  5. Adverse events (AEs)

    The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment.

    Measured: From the start of treatment to 28 days after the end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start25 Feb 2026 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389356
Sponsor's protocol ID
CSPC-DED-DLBCL-K16
Status last verified
Jan 2026
First submitted
17 Dec 2025
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide and Rituximab+Gemcitabine+Oxaliplatin in people with DLBCL - 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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?

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 Wei Xu (025-68306034, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (CRR) (time frame: every 2 cycles, up to 4 cycles (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 NCT07389356.

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 5 Feb 2026.

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