Understanding Chronic Lymphocytic Leukemia

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia

Detailed Description

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, for the potential development of more effective therapies for this disease.

• Study Type: Observational
• Enrollment (Estimated): 2750

Contacts and Locations

• Study Contact: Name: Jennifer Brown, MD, PhD; Phone Number: 617-582-8437; Email: Jennifer_brown@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Jennifer Brown, MD, PhD; Phone Number: 617-582-8437; Email: Jennifer_brown@dfci.harvard.edu
      • Principal Investigator: Jennifer Brown, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of novel genomic prognostic markers in Chronic Lymphocytic Leukemia	Exploratory science to better understand Chronic Lymphocytic Leukemia	20 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer Brown, MD,PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 1999
• Primary Completion (Estimated): September 29, 2030
• Study Completion (Estimated): September 29, 2032

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: 99-224; R01CA213442-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No