NCT04028531

Brief Summary

The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,750

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Sep 1999Sep 2032

Study Start

First participant enrolled

September 29, 1999

Completed
19.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2032

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

31 years

First QC Date

June 26, 2019

Last Update Submit

April 21, 2026

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of novel genomic prognostic markers in Chronic Lymphocytic Leukemia

    Exploratory science to better understand Chronic Lymphocytic Leukemia

    20 years

Study Arms (1)

Sample Collection

* Blood tests required for assessment * Specimens and data will also be collected from outside sites * Clinical data from patients with Chronic Lymphocytic Leukemia will be gathered into a database at Dana Farber Cancer Institute

Eligibility Criteria

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

Patients with Monoclonal B-cell lymphocytosis or Chronic Lymphocytic Leukemia in any phase of their disease.

You may qualify if:

  • New and existing patients seen for treatment of monoclonal B-cell lymphocytosis
  • Any low grade lymphoproliferative disorder
  • Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells, saliva

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

  • Jennifer Brown, MD,PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Brown, MD, PhD

CONTACT

617-582-8437Jennifer_brown@dfci.harvard.edu

Study Design

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

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 22, 2019

Study Start

September 29, 1999

Primary Completion (Estimated)

September 29, 2030

Study Completion (Estimated)

September 29, 2032

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Boston Childrens Hospital - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation Dana Farber Cancer Institute - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu Massachusetts General Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)