New chemo combo tested for returning lymphoma
NCT ID NCT07389356
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
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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
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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