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

Diffuse Large B Cell Lymphoma Clinical Trial

— BrUOG-377  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03719560
• Other study ID #: BrUOG-377
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Methotrexate
Systemic methotrexate
• Cytarabine
Systemic cytarabine

Locations

Country	Name	City	State
United States	Roxanne Wood	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion with clinically significant toxicity	Clinically significant toxicity as defined in the protocol	1 year
Secondary	Cumulative incidence of central nervous system recurrence	Cumulative incidence of central nervous system recurrence	2 years