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

NCT ID: NCT03719560

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CNS prophylaxis protocol

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

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Systemic methotrexate

Cytarabine

Intervention Type: DRUG

Systemic cytarabine

Interventions

Methotrexate

Systemic methotrexate

Intervention Type: DRUG

Cytarabine

Systemic cytarabine

Intervention Type: DRUG

Other Intervention Names

Methotrexate sodium; Cytosar-U

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam J Olszewski, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Roxanne Wood

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BrUOG-377

Identifier Type: -

Identifier Source: org_study_id