Low-grade B-cell malignancies, indolent Non-Hogdkin lymphoma, low-grade Non-Hogdkin lymphoma, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Follicular Lymphoma, FL, Marginal Zone Lymphoma, MZL, Lymphoplasmacytic Lymphoma, LPL, Hairy Cell Leukaemia, HCL, Indolent B-Cell Non-Hodgkin Lymphoma Not Otherwise Specified, B-Cell NHL NNO Chronic Lymphocytic Leukemia, non-aggressive lymph node cancer
Conditions
Interventions
Follow-up strategies:
Participants in arm A will be instructed to schedule visits upon request when they experience symptoms (patient-guided surveillance). Participants in arm B will be scheduled for
Sponsors
Albert Schweitzer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients with low-grade B-cell malignancies in active surveillance who never have received B-cell-malignancy-directed treatment.Subjects must have history of a low-grade B-cell malignancy confirmed either by histological biopsy or flow cytometry on blood or bone marrow, including:- Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)- Follicular Lymphoma, grade I-IIIa (FL)- Marginal Zone Lymphoma (MZL)- Lymphoplasmacytic Lymphoma (LPL)- Hairy Cell Leukaemia (HCL)- Indolent B-Cell Non-Hodgkin Lymphoma Not Otherwise Specified (B-Cell NHL NNO) Subjects are > 6 months in active surveillance and currently stable and don’t need therapySubjects are able to understand the survey questions used in the study.
Exclusion criteria
Exclusion criteria: Subjects with a history of intermediate or high-grade lymphoma, including:- Diffuse large B cell lymphoma (DLBCL) - Follicular lymphoma, grade IIIb- Mantle cell lymphoma- Hodgkin lymphomaFollow-up for another haematological indicationLife expectancy < 3 years Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate whether, in patients with low-grade B-cell malignancies, a patient-guided follow-up strategy provides similar (non-inferior) patient satisfaction compared with periodic active surveillance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters to be assessed:Number of visits to the haematology departmentSafety: predefined safety margin of a maximally acceptable 2.5% annual incidence of lymphoma-related death or irreversible organ injuryEvent-free survivalPatient-reported outcomes: mobility, self-care, daily activities, pain/discomfort, and anxiety/depressionTreatment choice and responseHealth care consumption | — |
Countries
Netherlands
Contacts
Public ContactJ.P. Kortleve
Albert Schweitzer Ziekenhuis
Outcome results
None listed