Clinical trial · Interventional
CNS Prophylaxis in Diffuse Large B-cell Lymphoma
Study Evaluating Relapses in Central Nervous System in Patients With Diffuse Large B-Cell Lymphoma Treated With Chemotherapy With or Without CNS Prophylaxis. Multicentric, Prospective, Randomized Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A - Methotrexate i.v.
- description
- Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive 2 cycles of methotrexate 3g/m2 i.v. after the 3rd and 6th cycle of systemic chemotherapy (R CHOP or DA EPOCH R).
- interventionNames
- Drug: Methotrexate
- type
- ACTIVE_COMPARATOR
- label
- Arm B - Methotrexate i.t.
- description
- Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive intrathecal methotrexate 12mg in each cycle of systemic chemotherapy (6x).
- interventionNames
- Drug: Methotrexate
- type
- NO_INTERVENTION
- label
- Arm C - no Methotrexate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed DLBCL * age 18-72 years * signed informed consent with the study * first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR Exclusion Criteria: * DLBCL and concomitant initial CNS involvement * PMBL (primary mediastinal B-cell lymphoma) * treatment with another chemotherapy than R CHOP or DA EPOCH R * HIV positive, or active hepatitis B or C * other concomitant serious disease (based on the decision of the physician-investigator) * non-compliance of a patient * any contraindication for application of anthracycline based chemotherapy or high dose methotrexate * pregnancy or breast-feeding
References
Publications (0)
Data not yet available