Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)

NCT ID: NCT06098430

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2028-01-31

Brief Summary

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There is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). This study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (PROs) instruments.

Primary Objective:

* To develop the data collection infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with NLPHL.

Secondary Objective:

* To examine differences in baseline and longitudinal changes in PROs based on disease characteristics, disease status, and treatment strategies among adult and pediatric patients diagnosed with NLPHL.

Detailed Description

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The broad aim of this study is to develop the foundational data management infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The study team further aims to elucidate how PROs change over time and how they may be affected by different patient, disease, and treatment characteristics.

Conditions

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Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 8 years
* Patient or their adult proxy must have verbal and written English language proficiency.
* Pathologically confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible.
* Patients or their adult proxy must be able to provide consent.
* Patients and/or adult proxy must be able to complete electronic quality of life surveys

Exclusion Criteria

* Age 7 years or less.
* Patient or adult proxy does not have verbal and written English language proficiency.
* Patients with histologic evidence of a composite lymphoma (NLPHL with a concurrent diagnosis of Hodgkin lymphoma, indolent non-Hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible.
* Inability or unwillingness of research participant or legal guardian/representative to give consent.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Crabtree, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Ajay Major, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Anna Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Matthew Rees, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Jamie Flerlage, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

The University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Valerie Crabtree, PhD

Role: CONTACT

866-278-5833

Jessi Rogers Blake, BSN, RN,CCRP

Role: CONTACT

901-595-4108

Facility Contacts

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Ajay Major, MD, MBA

Role: primary

720-848-0300

Angela Feraco, MD

Role: primary

888-733-4662

Christopher Forlenza, MD

Role: primary

212-639-5226

Jamie Flerlage, MD, MS

Role: primary

585-275-2981

Role: primary

866-278-5833

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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NCI-2023-08916

Identifier Type: REGISTRY

Identifier Source: secondary_id

NLPHLPRO

Identifier Type: -

Identifier Source: org_study_id

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