NCT01028430

Brief Summary

B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for \~25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is \~2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In \~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

25.2 years

First QC Date

December 8, 2009

Last Update Submit

March 25, 2024

Conditions

Keywords

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • expression of cell surface antigens HLA-DR and CD38+ markers in B-CLL cells compared to normal B-lymphocytes

    samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6.

Study Arms (1)

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Lymphocytic Leukemia Community Sample

You may qualify if:

  • years of age Patients must be willing to be contacted in the future

You may not qualify if:

  • Patients who are known to be anemic, with a hemoglobin \<8 PAtients who are known to be infected with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Biospecimen

Blood cells, tissue

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas Chiorazzi, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

July 1, 1998

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations