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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 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


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 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

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 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