Actively Recruiting
R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse
Led by Fudan University · Updated on 2026-04-02
83
Participants Needed
2
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double-center, single-arm, phase 2 study to evaluate the efficacy and safety of R-CDOP regimen combined with intrathecal methotrexate in chemo-naive diffuse large B-cell lymphoma patients with high-risk of CNS relapse.
CONDITIONS
Official Title
R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status of 0 to 2
- Untreated diffuse large B-cell lymphoma confirmed by pathology
- High risk of CNS recurrence defined by CNS-IPI score 4-6 or lymphoma involvement in specific organs (testis, breast excluding unilateral small masses, adrenal gland, kidney, paranasal sinus, paravertebral, bone marrow, etc.) or primary cutaneous large B-cell lymphoma of the leg
- At least one measurable lesion (lymph nodes >1.5 cm or extranodal lesions >1.0 cm)
- Normal bone marrow function with specific blood count thresholds unless abnormalities due to lymphoma infiltration
- Liver function with total bilirubin, ALT, AST less than 1.5 times the upper limit of normal
- Renal function with creatinine less than 1.5 times upper limit of normal and clearance ≥30 ml/min
- Heart function with left ventricular ejection fraction ≥50%
- Agreement to use contraception if in reproductive age and negative pregnancy test for women
- Consent to provide pathological tissue samples
- Life expectancy of at least 3 months
- Signed informed consent
You will not qualify if you...
- Severe allergy to humanized or murine monoclonal antibodies or contraindication to R-CDOP or intrathecal methotrexate
- Evidence of CNS lymphoma involvement at baseline
- Certain lymphoma subtypes not suitable for R-CDOP induction therapy (e.g., PMBCL, double-hit lymphoma)
- Significant cardiac conditions including severe insufficiency, recent heart attack, unstable angina, or prolonged QT interval
- Major surgery within 3 weeks before treatment
- Other active malignancies except certain treated skin or cervical cancers
- Significant blood clotting abnormalities
- Prior lymphoma treatment other than short-term corticosteroids
- Severe active infections
- Other serious uncontrolled health conditions that may affect study participation
- Active hepatitis B or C infections or other immune deficiencies including HIV
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dongmei Ji
Shanghai, Shanghai Municipality, China, 021
Actively Recruiting
2
Cancer Hospital affilicaited to Xinjiang Medical University
Ürümqi, Xinjiang, China
Not Yet Recruiting
Research Team
D
Dongmei Ji, doctor
CONTACT
J
Junning Cao, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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