Understanding Chronic Lymphocytic Leukemia | NCT04028531

Studies
Understanding Chronic Lymphocytic Leukemia

NCT04028531

Sponsor

Dana-Farber Cancer Institute

Status

Recruiting

Last Update Posted

Apr 24, 2026Actual

Enrollment

2,750Estimated

Phase

Not provided

Conditions

Chronic Lymphocytic Leukemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01CA213442-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 1999Actual

Primary Completion Date

Sep 29, 2030Estimated

Completion Date

Sep 29, 2032Estimated

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jul 19, 2019

First Posted Date

Jul 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 24, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer Brown, MD, PhD	Contact	617-582-8437		Jennifer_brown@dfci.harvard.edu

Overall Officials

Name	Affiliation	Role
Jennifer Brown, MD,PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana Farber Cancer Institute	Recruiting	Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided