New combo aims to stop lymphoma from spreading to the brain
NCT ID NCT05257018
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 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: 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;
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diffuse large B cell lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGÜrümqi, Xinjiang, China
-
Dongmei Ji
RECRUITINGShanghai, Shanghai Municipality, 021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas
- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?
- New drug joins standard chemotherapy in fight against B-Cell lymphoma