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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 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
1 Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab
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
MeSH:Lymphoproliferative Disorders
HPO:Lymphoproliferative disorder
Primary Outcomes
Measure: Objective response rate (ORR) Time: 2 yearsSecondary Outcomes
Measure: Overall survival (OS) Time: 5 yearsMeasure: 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
2 Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy
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
MeSH:Lymphoproliferative Disorders
HPO:Lymphoproliferative disorder
Primary Outcomes
Measure: Objective response rate (ORR) in the SOT or HCT cohort Time: 2 yearsSecondary Outcomes
Measure: Duration of response (DOR) in SOT and HCT cohorts separately Time: 2 yearsMeasure: 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