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NCT05199961 · ClinicalTrials.gov registry record · NA
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
A NA study, sponsored by Pack Health.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT05199961: Clinical Trial NA study, sponsored by Pack Health.
NCT05199961 is a NA study that was terminated before completion, run by Pack Health. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05199961, a NA study, was terminated before completion, sponsored by Pack Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.
Primary Outcome
The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.
Interventions
- BEHAVIORAL Digital Health Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2022-09-13 |
| Phase | NA |
Why NCT05199961 stopped before completion
NCT05199961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Digital Health Coaching is the first listed.
NCT05199961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05199961 about?
NCT05199961 is a clinical study titled "Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel". The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individual...
What is the current status of trial NCT05199961?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2022-01-25. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT05199961?
The interventions under investigation include: Digital Health Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT05199961?
This trial is sponsored by Pack Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05199961's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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