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New combo aims to stop lymphoma from spreading to the brain

NCT ID NCT05257018

What the study statuses mean

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Recruitment status, easiest to join first

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a chemotherapy regimen (R-CDOP) plus a drug injected into the spine (intrathecal methotrexate) in 83 adults with untreated diffuse large B-cell lymphoma at high risk of spreading to the brain. The goal is to see if this combination lowers the chance of central nervous system relapse within two years. Participants must be 18-75 and have specific high-risk features.

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 83 people

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

Started

Feb 2022

Expected to finish

Dec 2028

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 to 75 years

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: 1. Age range from 18 to 75 years; 2. ECOG performance status: 0-2; 3. Histopathologically confirmed untreated diffuse large B-cell lymphoma (cell origin can be distinguished according to Hans algorithm) , And fulfilled the following criteria for high-risk CNS recurrence: 1. CNS-IPI 4-6; 2. The lymphoma involved testis, breast (excluding unilateral breast and less than 5 cm mass), adrenal gland, kidney, paranasal sinus, paravertebral, and bone marrow and other sites; 3. PCLBCL-leg; 4. Subjects have at least one measurable lesion: the long axis of the lymph node shall be\>1.5 cm, the long axis of the extranodal lesions shall be\>1.0 cm; 5. Bone marrow hematopoiesis was essentially normal: WBC≥3.5 ×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥90 g/L. Abnormal peripheral blood indices, as a result of lymphoma invading the bone marrow or spleen, permitted enrollment at the discretion of the investigator; 6. Liver function: total bilirubin, ALT, AST \< 1.5×UNL (upper limit of normal); 7. Renal function: Cr \< 1.5×UNL and creatinine clearance≥30 ml/min; 8. Echocardiography or nuclide cardiac function testing with LVEF≥50%; 9. Patients in the reproductive period agreed to appropriate contraception. Women in the reproductive period had a negative serum pregnancy test within 2 weeks before enrollment; 10. Consent to provide pathological tissue specimens (wax blocks within half a year or 20 slides for paraffin tissue sections); 11. Life expectancy≥3 months; 12. Signed informed consent; Exclusion Criteria: 1. Patients with a known history of severe allergy to humanized or murine mAbs, or any contraindication to R-CDOP, intrathecal MTX; 2. Patients with evidence of CNS involvement (baseline cerebrospinal fluid, imaging, symptoms); 3. Special types of diffuse large B-cell lymphoma patients who are not suitable for induction therapy with R-CDOP, such as PMBCL, double-hit large B-cell lymphoma, etc; 4. Clinically significant cardiac conditions, including severe cardiac insufficiency: New York Heart Association (NYHA) cardiac insufficiency class IV, unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and Q-Tc interval greater than 500 ms; 5. Those who had a second degree or greater operation within three weeks before treatment; 6. Diagnosed with a malignancy other than lymphoma or under treatment, with the following exceptions: 1. Had received treatment with curative intent and had not developed malignancy with known active disease ≥ 5 years prior to enrollment; 2. Basal cell carcinoma of the skin (other than melanoma) that has been adequately treated with no evidence of disease; 3. Carcinoma in situ of the cervix that has been adequately treated with no evidence of disease; 7. Had significant coagulation abnormalities; 8. Any previous antilymphoma therapy other than short-term corticosteroids (up to 10 days); 9. Those with severe active infection; 10. Other serious, uncontrolled concomitant conditions that may affect protocol adherence or interfere with interpretation of results include uncontrolled diabetes mellitus, or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease, and a history of symptomatic bronchospasm), hypertension, and others; 11. HBV (HBsAg positive and HBV-DNA ≥ 104 IU / ml), HCV (HCV antibody positive and HCV-RNA measurable); And subjects with other acquired, congenital immunodeficiency diseases, including but not limited to those with HIV infection; 12. Pregnant or lactating women;

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Cancer Hospital affilicaited to Xinjiang Medical University

    NOT_YET_RECRUITING

    Ürümqi, Xinjiang, China

  • Dongmei Ji

    RECRUITING

    Shanghai, Shanghai Municipality, 021, China

More trials for these conditions

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