Clinical trial · Interventional
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
NCT03719560CI-TRIAL-00044617BrUOG-377withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CNS prophylaxis protocol
- description
- Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.
- interventionNames
- Drug: Methotrexate
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Proportion with clinically significant toxicity
- timeFrame
- 1 year
- description
- Clinically significant toxicity as defined in the protocol
Secondary outcomes (1)
- measure
- Cumulative incidence of central nervous system recurrence
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens * No central nervous system involvement on initial staging * Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale) * Renal function: creatinine clearance \>45 ml/min * Not pregnant; agreeable to contraception * Written informed consent * High risk for central nervous system recurrence as determined by one of the following high-risk features: 1. high central nervous system International Prognostic Index, 2. testicular, breast, or uterine involvement, 3. dual expresser or double/triple-hit status, 4. HIV positive status, or 5. Molecularly defined high-risk subtype. Exclusion Criteria: * pregancy * unable to provide informed consent * significant comorbidity in the investigator's judgement
References
Publications (0)
Data not yet available
No reference posted for this study.