Diffuse Large B Cell Lymphoma
Conditions
Brief summary
Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma
Detailed description
This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.
Interventions
DRUGMethotrexate
Systemic methotrexate
DRUGCytarabine
Systemic cytarabine
Sponsors
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion with clinically significant toxicity | 1 year | Clinically significant toxicity as defined in the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of central nervous system recurrence | 2 years | Cumulative incidence of central nervous system recurrence |
Countries
United States
Outcome results
None listed