Patient-derived Siglec-6-targeting antibodies engineered for T-cell recruitment have potential therapeutic utility in chronic lymphocytic leukemia.
Matthew G Cyr, Maissa Mhibik, Junpeng Qi...
https://pubmed.ncbi.nlm.nih.gov/36442911Actively Recruiting
Age: 18Years - 110Years
All Genders
ID00923507
Natural History Study of Monoclonal B Cell Lymphocytosis, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia, and Splenic Marginal Zone Lymphoma
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-08
1000
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the natural history and clinical progression of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). This observational study aims to understand disease stability, progression, and molecular events in patients before and after treatment, which may help identify new treatment targets. The study does not provide treatment but focuses on collecting detailed clinical and biological data to advance knowledge of these conditions. Participants with these diagnoses are followed regularly, typically every 6 to 24 months, and may have blood samples, bone marrow biopsies, lymph node biopsies, PET scans, CT scans, and MRI scans taken. Some procedures support clinical care, while others are for research purposes. Patients may donate blood, tissue, and imaging data to aid translational research into the molecular basis of these diseases and their progression. During the study, participants undergo periodic clinical assessments and sample collections to monitor their condition. Clinical data and biological information are stored centrally for research. The main outcome measured is the time patients remain treatment-free until their disease requires therapy. Patients are monitored for disease status, and if treatment becomes necessary, other clinical trial options or treatments are discussed. Participation involves ongoing follow-up visits and assessments, with no study treatment administered.
CONDITIONS
Brief Title
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Who Can Participate
Age: 18Years - 110Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to NCI criteria, including patients on treatment, previously treated, or nearing first-line treatment
- Diagnosis of lymphoplasmacytic lymphoma or Waldenstrom macroglobulinemia confirmed by immunophenotyping
- Age 18 years or older
- ECOG performance status between 0 and 2
- Ability to understand the study and provide informed consent
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Ongoing with visits every 6 to 12 months for the first 2 years, then every 12 to 24 months thereafter
Participants are followed regularly to collect blood, tissue samples, and imaging studies to help understand the natural history and progression of their condition.
Visits every 6 to 12 months for 2 years, then every 12 to 24 months thereafter, with interim visits as needed
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
I
Ingrid C Frey
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The immune microenvironment shapes transcriptional and genetic heterogeneity in chronic lymphocytic leukemia.
Clare Sun, Yun-Ching Chen, Aina Martinez Zurita...
https://pubmed.ncbi.nlm.nih.gov/35358998