Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of allogeneic HCT after failure of rituximab. Tabelecleucel will be selected for the subject from the bank of available tabelecleucel cell products based on matching >= 2 human leukocyte antigen (HLA) alleles, at least one of which is a restricting HLA allele, shared between the tabelecleucel donor and the subject's EBV+ PTLD. Sites will provide high resolution subject and subject's graft donor HLA typing results and other information as required by the protocol. Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) tabelecleucel at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. NOTE, 29 April 2020: Study sites/locations with status "completed" may be screening EBV+ PTLD HCT subjects in clinical study ATA129-EBV-302 (NCT03394365). NOTE, 16 February 2021: all study sites have closed and all data has been transferred to the clinical study database for monitoring under ATA129-EBV-302 (NCT03394365). ;


Study Design


Related Conditions & MeSH terms

  • Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
  • Lymphoproliferative Disorders
  • Stem Cell Transplant Complications

NCT number NCT03392142
Study type Interventional
Source Atara Biotherapeutics
Contact
Status Completed
Phase Phase 3
Start date December 29, 2017
Completion date February 16, 2021

See also
  Status Clinical Trial Phase
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Recruiting NCT06080490 - Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
Completed NCT03042676 - Electronic Database for the Follow up of the ATG_FamilyStudy
Recruiting NCT03871296 - DNA Methylation in Allogeneic Hematopoietic Stem Cell Transplantation.
Not yet recruiting NCT06022445 - Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT
Recruiting NCT04502628 - Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis Post HSCT N/A
Recruiting NCT03793517 - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT Phase 2/Phase 3
Completed NCT03454568 - The Patients' Experience After Stem Cell Transplant
Recruiting NCT05466201 - The Use of Eltrombopag Post HSCT in BMFS Phase 2/Phase 3
Not yet recruiting NCT04080622 - Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation. Phase 3
Recruiting NCT05523336 - Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation
Completed NCT03355235 - Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
Completed NCT04888286 - DSAs in Patients Undergoing Allo-HSCT From Mismatched Donors
Not yet recruiting NCT05421416 - Loratadine for the Prevention of G-CSF-related Bone Pain Phase 2
Recruiting NCT04167683 - Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant
Active, not recruiting NCT03967665 - Risk Stratification-directed NAC for Prevention of Poor Hematopoietic Reconstitution Phase 3
Withdrawn NCT05104268 - Study of a New Medical Device for Oral Mucositis Early Phase 1
Recruiting NCT04623424 - Intestinal Microbiota in Stem Cell Transplant Transplant Admission
Active, not recruiting NCT04669210 - PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT Phase 2
Completed NCT03489551 - Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients Phase 4