Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06098430

Conditions

Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Study ID

NCT06098430

Start date

Apr 4, 2024

Status verified date

May, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Estimates of response rates [ Time Frame: At baseline, 3, 6, 9, and 12 months ]
  • Patterns of individual per-patient survey completion [ Time Frame: At baseline, 3, 6, 9, and 12 months ]

Central Contacts and Locations

Central contacts

Valerie Crabtree, PhD

888-226-4343referralinfo@stjude.org

Jessi Rogers Blake, BSN,RN,CCRP

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

Locations

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Michael Binkley, MD

650-736-0921msb996@stanford.edu

Principal Investigator:

Michael Binkley, MD

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Ajay Major, MD, MBA

720-848-0300ajay.major@cuanschutz.edu

Principal Investigator:

Ajay Major, MD, MBA

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Angela Feraco, MD

888-733-4662Angela_Feraco@dfci.harvard.edu

Principal Investigator:

Angela Feraco, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 08837

Contacts

Burton Appel, MD, MBA

551-996-5437burton.appel@hmhn.org

Principal Investigator:

Burton Appel, MD, MBA

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Christopher Forlenza, MD

212-639-5226Forlenzc@MSKCC.org

Principal Investigator:

Christopher Forlenza, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Jamie Flerlage, MD, MS

585-275-2981jamie_flerlage@urmc.rochester.edu

Principal Investigator:

Jamie Flerlage, MD, MS

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Valerie Crabtree, PhD

888-226-4343referralinfo@stjude.org

Jessi Rogers Blake, BSN,RN,CCRP

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

Principal Investigator:

Valerie Crabtree, PhD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-20.