Covid 19 Research using Clinical Trials (Home Page)
Report for D008232: Lymphoproliferative Disorders NIH
(Synonyms: Lymphoprolifera, Lymphoproliferati, Lymphoproliferative Disorder, Lymphoproliferative Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (1)
|
Name (Synonyms) |
Correlation |
drug3021 | tabelecleucel Wiki | 1.00 |
Correlated MeSH Terms (0)
|
Name (Synonyms) |
Correlation |
Correlated HPO Terms (1)
|
Name (Synonyms) |
Correlation |
HP:0005523 | Lymphoproliferative disorder HPO | 1.00 |
There are 2 clinical trials
Clinical Trials
This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and
safety of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell
transplant (HCT) after failure of rituximab.
NCT03392142 Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Stem Cell Transplant Complications Lymphoproliferative Disorders Biological: tabelecleucel
Primary Outcomes
Measure: Objective response rate (ORR) Time: 2 years
Secondary Outcomes
Measure: Overall survival (OS) Time: 5 years
Measure: Duration of response (DOR) Time: 2 years
Measure: PTLD progression-free survival (PFS) following best response Time: 2 years
Measure: Rate of durable response Time: 2 years
Measure: Time to progression Time: 2 years
Measure: Patient reported outcome: EQ-5D Time: 2 years
Measure: Patient reported outcome: Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Time: 2 years
Measure: Incidence of related and unrelated adverse events (AE), including AEs of special interest Time: 2 years
The purpose of this study is to determine the clinical benefit and characterize the safety
profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT)
after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic
cell transplant (HCT) after failure of rituximab.
NCT03394365 Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications Biological: tabelecleucel
Primary Outcomes
Measure: Objective response rate (ORR) in the SOT or HCT cohort Time: 2 years
Secondary Outcomes
Measure: Duration of response (DOR) in SOT and HCT cohorts separately Time: 2 years
Measure: ORR and DOR in SOT and HCT cohorts combined Time: 2 years
Measure: Rates of complete response (CR) and partial response (PR) Time: 2 years
Measure: Time to response Time: 2 years
Measure: Time to best response Time: 2 years
Measure: Overall survival (OS) Time: 2 years
Measure: Rates of allograft loss or rejection episodes (SOT cohort) Time: 2 years
HPO Nodes