A data and sample collection study for patients with diffuse large B-cell lymphoma

Not Applicable

• Conditions: Diffuse large B-cell lymphoma; Cancer

• Registration Number: ISRCTN17717066
• Lead Sponsor: Clatterbridge Cancer Centre NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-16
• Last Update Posted: 27 March 2023
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Males and female subjects =16 years of age at the time of enrolment
2. Ability to understand and sign written informed consent
3. Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to current World Health Organisation 2016 guidelines that fall into one of two cohorts that will be independently evaluated/reported:
3.1. DLBCL patients with de novo disease unfit for full dose R-CHOP
OR
3.2. DLBCL patients with relapsed/refractory disease
4. Patients fulfilling the above criteria who are on other trials/studies are eligible for recruitment

Exclusion Criteria

Patients commencing index treatments >6 months prior to trial enrolment (Cohorts A or B). In other words, patients can be retrospectively entered (for Cohorts A or B). This exclusion does not apply to prior therapies before the index treatment event for Cohort B.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 12 months (PFS12), defined as disease progression or recurrence, or death from any cause (defined as days from the date of cohort assignment to event) occurring within 12 months (from the date of cohort assignment) as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016)