Lymphoma, Large B-Cell, Diffuse Clinical Trial
Official title:
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 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03977623 -
Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
|
||
| Recruiting |
NCT02428751 -
R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
|
Phase 3 | |
| Completed |
NCT02555267 -
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma
|
||
| Active, not recruiting |
NCT02364050 -
Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM
|
||
| Terminated |
NCT00529503 -
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
|
Phase 2 | |
| Terminated |
NCT02413489 -
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
|
Phase 2 | |
| Completed |
NCT02086604 -
Brentuximab Vedotin and Lenalidomide for Relapsed or Refractory Diffuse Large B-cell Lymphoma
|
Phase 1 | |
| Completed |
NCT01421524 -
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT03600363 -
A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients
|
Phase 2 | |
| Recruiting |
NCT03646422 -
AEDV Registry of Primary Cutaneous Lymphoma
|
||
| Recruiting |
NCT04446962 -
LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03241017 -
Durvalumab in DLBCL After Autologous Transplant
|
Phase 2 | |
| Recruiting |
NCT02931201 -
Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma
|
N/A | |
| Recruiting |
NCT02928861 -
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma
|
N/A | |
| Terminated |
NCT02592876 -
Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma
|
Phase 2 | |
| Completed |
NCT00849147 -
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
|
Phase 2 | |
| Completed |
NCT00822432 -
Coproporphyrine Isomers and Methotrexate Elimination
|
N/A | |
| Completed |
NCT03682796 -
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04982471 -
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
|
||
| Completed |
NCT03744676 -
A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)
|
Phase 2 |