Nodular Lymphocyte-Predominant Hodgkin LymphomaNCT06098430
Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
An observational study of Nodular Lymphocyte-Predominant Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Nodular Lymphocyte-Predominant Hodgkin Lymphoma
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Apr 2024to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that meet eligibility
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Ajay Major, MD, MBA, 720-848-0300, ajay.major@cuanschutz.edu
Ajay Major, MD, MBA
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Angela Feraco, MD, 888-733-4662, Angela_Feraco@dfci.harvard.edu
Angela Feraco, MD
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 08837
Burton Appel, MD, MBA, 551-996-5437, burton.appel@hmhn.org
Burton Appel, MD, MBA
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Valerie Crabtree, PhD, 888-226-4343, referralinfo@stjude.org
Jessi Rogers Blake, BSN,RN,CCRP, 901-595-4108, jessi.rogers-blake@stjude.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christopher Forlenza, MD, 212-639-5226, Forlenzc@MSKCC.org
Christopher Forlenza, MD
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94304
Michael Binkley, MD, 650-736-0921, msb996@stanford.edu
Michael Binkley, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Jamie Flerlage, MD, MS, 585-275-2981, jamie_flerlage@urmc.rochester.edu
Jamie Flerlage, MD, MS
About this study
Official title: A Pilot Study of Prospective Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
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:
Read more
- 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.
Read the detailed description
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.
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimates of response rates
Percentage of survey completion at different timepoints
Measured: 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.
Measured: At baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start4 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodular Lymphocyte-Predominant Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Crabtree, PhD, Principal investigator, St. Jude Children's Research HospitalAjay Major, MD, MBA, Principal investigator, University of Colorado, DenverAnna Jones, PhD, Principal investigator, St. Jude Children's Research HospitalMatthew Rees, MD, Principal investigator, St. Jude Children's Research HospitalJamie Flerlage, MD, MS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098430
- Sponsor's protocol ID
- NLPHLPRO
- Other IDs
- NCI-2023-08916
- Status last verified
- May 2026
- First submitted
- 17 Oct 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Prospective Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
- ClinicalTrials.gov ID
- NCT06098430
- Acronym / sponsor ID
- NLPHLPRO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that meet eligibility
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimates of response rates
Time frame: At baseline, 3, 6, 9, and 12 months
Percentage of survey completion at different timepoints
Patterns of individual per-patient survey completion
Time frame: At baseline, 3, 6, 9, and 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
Ann Arbor Stage I Hodgkin Lymphoma, Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma
Active, not recruitingPhase 2/3
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 3
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma
RecruitingPhase 2
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valerie Crabtree, PhD principal investigator
St. Jude Children's Research Hospital
Ajay Major, MD, MBA principal investigator
University of Colorado, Denver
Anna Jones, PhD principal investigator
St. Jude Children's Research Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodular Lymphocyte-Predominant Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Crabtree, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimates of response rates (time frame: At baseline, 3, 6, 9, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.