NCT06098430

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

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 Progress53%
Apr 2024Jan 2028

First Submitted

Initial submission to the registry

October 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

October 17, 2023

Last Update Submit

March 27, 2026

Conditions

Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Estimates of response rates

    Percentage of survey completion at different timepoints

    At baseline, 3, 6, 9, and 12 months

  • Patterns of individual per-patient survey completion

    Patterns of individual per-patient survey completion will be described. Non-responders, late responders, and patients with suboptimal item completion rates who require real-time outreach will be queried for individual challenges in completing PRO surveys for iterative improvements to infrastructure.

    At baseline, 3, 6, 9, and 12 months

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that meet eligibility

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University Medical Center

Palo Alto, California, 94304, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 08837, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Valerie Crabtree, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

  • Ajay Major, MD, MBA

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Anna Jones, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

  • Matthew Rees, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

  • Jamie Flerlage, MD, MS

    University of Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Crabtree, PhD

CONTACT

866-278-5833referralinfo@stjude.org

Jessi Rogers Blake, BSN, RN,CCRP

CONTACT

901-595-4108jessi.rogers-blake@stjude.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 24, 2023

Study Start

April 4, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

US(7)