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Immunotherapy-Chemo combo shows promise in aggressive lymphoma trial

NCT ID NCT03749018

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding the immunotherapy drug nivolumab to a standard chemotherapy regimen (DA-REPOCH) can improve outcomes for people with aggressive B-cell non-Hodgkin lymphoma. The study enrolls 30 patients with various subtypes of the disease. The main goal is to see how long patients live without their cancer progressing after this combination treatment.

What this could mean

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

Active substance
nivolumab (an immunotherapy drug) combined with DA-REPOCH chemotherapy
What this could lead to
If successful, this could offer a more effective treatment option for aggressive B-cell lymphoma, potentially improving how long patients live without their cancer worsening.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to everyone. Adding immunotherapy to chemo can also increase side effects like immune-related inflammation.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Jan 2019

Expected to finish

Dec 2026

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: * Be willing and able to provide written informed consent/assent for the trial. * Measurable disease (defined as \>= 1.5 cm in diameter) or at least one PET avid area of disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Absolute neutrophil count (ANC) \>= 1,000 /mcL (within 16 days of treatment initiation). * Platelets \>= 75,000 / mcL in the absence of transfusion support within 7 days of determining eligibility (within 16 days of treatment initiation). * Hemoglobin \>= 8 g/dL (within 16 days of treatment initiation). * Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 40 mL/min creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) (within 16 days of treatment initiation). * Creatinine clearance should be calculated per institutional standard. * Serum total bilirubin =\< 1.5 X ULN OR except subjects with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL (within 16 days of treatment initiation). * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 X ULN (within 16 days of treatment initiation). * Female subject of childbearing potential should have a negative serum pregnancy at screening. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months following the last dose of nivolumab. Subjects should agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months following the last dose of nivolumab. Males must refrain from donating sperm during study participation and for 7 months after the last dose of nivolumab. * Revised Ann Arbor stage II-IV disease * Stage I primary mediastinal B-cell lymphoma or mediastinal B cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin?s lymphoma will also be eligible. * Be willing and able to understand and give written informed consent and comply with all study related procedures. Exclusion Criteria: * Known hypersensitivity to any of the study drugs. * History of other malignancy that could affect compliance with the protocol or interpretation of the results. * Has a diagnosis of immunodeficiency excluding human immunodeficiency virus (HIV) infection or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Subjects may use topical or inhaled corticosteroids or low-dose steroids (=\< 10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. During study participation, subjects may receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions. * Has a known history of active TB (Bacillus tuberculosis). * Prior systemic chemotherapy for lymphoma with the exception of corticosteroids for palliation of symptoms and patients with prior indolent non-Hodgkin lymphoma (NHL) treated with single agent rituximab. * Has known active central nervous system (CNS) lymphoma. * Richter?s transformation from chronic lymphocytic leukemia (CLL). * Major surgery within 3 weeks prior to start of study treatment. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Conditions expected to not recur in the absence of an external trigger. * Has an active infection requiring intravenous systemic therapy or uncontrolled systemic infection including viral, bacterial, or fungal. * Is unable to swallow capsules or malabsorption syndrome, disease or condition significantly affecting gastrointestinal function. * Clinically significant cardiovascular disease, including uncontrolled arrhythmia, New York Association class 2- 4 congestive heart failure, or history of myocardial infarction within 6 months. * Known contraindication to any medication in the treatment plan, including clinically significant peripheral neuropathy. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Female patients who are not surgically sterile or postmenopausal (for at least 1 year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 5 months after study treatment: * Total abstinence from hetero-sexual intercourse * A vasectomized partner * Hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) that started at least 3 months prior to study drug administration * Double-barrier method (condom + diaphragm or cervical cup with spermicidal contraceptive sponge, jellies, or cream) * Non-vasectomized male patients must comply with at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment: * A partner who is surgically sterile or postmenopausal (for at least 1 year) or who is taking hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) for at least 3 months prior to study drug administration * Total abstinence from hetero-sexual intercourse * Double-barrier method (condom + diaphragm or cervical cup with spermicidal, contraceptive sponge, jellies, or cream). * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. * Acute hepatitis C (defined as positive hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\] and diagnosis within the past 6 months). * Positive hepatitis C antibody with evidence of cirrhosis. * Active hepatitis B (subjects with a positive hepatitis B virus \[HBV\] core antibody or surface antigen are eligible as long as they have an undetectable HBV DNA polymerase chain reaction \[PCR\] and receive concurrent antiviral therapy with entecavir or tenofovir, and continued for a minimum of 6 months after completion of therapy). * HIV infection AND CD4 count \< 100 cells/ mm\^3, evidence of resistant strain of HIV, or HIV viral load \>= 50 copies HIV RNA/mL if on highly active antiretroviral therapy (HAART) or HIV viral load \>= 10,000 copies HIV RNA/mL if not on anti-HIV therapy.

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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.

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.