Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma

• Status: Withdrawn
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Treatments: Cytarabine; Methotrexate

Criteria

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