Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma (BrUOG-377)

Brown University

Status and phase: Withdrawn; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Methotrexate; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03719560

BrUOG-377

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

CNS prophylaxis protocol

Experimental group

Description:

Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.

Treatment:

Drug: Cytarabine

Drug: Methotrexate