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New chemo combo tested for returning lymphoma

NCT ID NCT07389356

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase II trial will test two different drug combinations in 70 people whose diffuse large B-cell lymphoma has returned more than a year after initial treatment. One group gets a modified R-MINE regimen (rituximab, ifosfamide, mitoxantrone liposome, etoposide), the other gets R-GemOx (rituximab, gemcitabine, oxaliplatin). The goal is to see which combination works better at shrinking tumors and controlling the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab, ifosfamide, mitoxantrone liposome, etoposide (modified R-MINE) vs rituximab, gemcitabine, oxaliplatin (R-GemOx)
What this could lead to
If successful, this trial could identify a more effective chemotherapy regimen for patients whose diffuse large B-cell lymphoma has returned more than a year after initial treatment.
What could go wrong
This is a small, early-phase (phase II) study with only 70 participants, so results may not apply to all patients. Both regimens involve strong chemotherapy with significant side effects, and the trial has not yet started recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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). Exclusion Criteria: * Previous history of antitumor therapy meeting any of the following conditions: 1. Prior treatment with mitoxantrone or liposomal mitoxantrone; 2. 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); 3. Prior autologous hematopoietic stem cell transplantation within 100 days before the first dose, or a history of allogeneic hematopoietic stem cell transplantation; 4. 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; * Uncontrolled systemic diseases (e.g., progressive infections, uncontrolled hypertension, diabetes, etc.); * Cardiac function and diseases meeting any of the following conditions: 1. Long QTc syndrome or QTc interval \>480 ms; 2. Complete left bundle branch block, complete right bundle branch block with left anterior fascicular block, type II second-degree or third-degree atrioventricular block; 3. Severe, uncontrolled arrhythmia requiring medication; 4. New York Heart Association Class ≥ III; 5. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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