A Study on Fractionated Rituximab to Avoid Lysis Syndrome in Aggressive B-Lymphoma

NCT05840289 | Unknown

• 1 other identifier: 2020-01659
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Tumour lysis syndrome (TLS) occurs as a consequence of the rapid destruction of malignant cells, spontaneously and/or in response to cytotoxic agents and immunotherapies. TLS is a feature of highly proliferative diseases with heavy tumor burden, such as high-grade non-Hodgkin lymphomas (NHL, typically Burkitt's lymphoma). We evaluated fractionating first rituximab dose to prevent TLS in a real-life B-cell NHL cohort of patients treated at University Hospital of Geneva between 2010 and 2020.

Conditions

Aggressive B-Cell Non-Hodgkin Lymphoma

Keywords

Aggressive B-cell non-Hodgkin lymphoma; tumor lysis syndrome; fractionated rituximab; prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of clinical lysis syndrome (CTLS) in patients receiving fractionated Rituximab infusion for high-grade B-cell lymphoma.

  To evaluate the incidence of clinical tumor lysis syndrome (CTLS) in patients receiving fractionated Rituximab infusion for high-grade B-cell lymphoma.

  10 days (day -2 and day + 7 after first rituximab infusion)

Secondary Outcomes (1)

• Incidence of biochemical lysis syndrome (LTLS) in patients receiving fractionated Rituximab infusion for high-grade B-cell lymphoma.

  10 days (day -2 and day + 7 after first rituximab infusion)

Interventions

fractionated first dose rituximab OTHER

Patients at high-risk to develop tumor lysis syndrome received a initial fractionated dose of rituximab over 2 or 3 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

histologically proven high-grade B-cell lymphoma patients

You may qualify if:

• Newly diagnosed or relapsing histologically proven high-grade B-cell lymphoma patients treated with fractionated Rituximab infusion, considered as ≥ 2 consecutive infusions, at least 24 hours apart

You may not qualify if:

• Unproven histologically high-grade B-cell lymphoma
• Patients who receive a single day Rituximab infusion
• Patients under long-term dialysis before Rituximab started
• Age ≤ 18 years
• Absence of written informed consent

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Tumor Lysis Syndrome

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Noemie Lang, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: August 24, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 10 years
• Access Criteria: Upon reasonable scientific request

Locations

CH (1)