Clinical Trials Logo
  1. Home
  2. Anaplastic Large Cell Lymphoma
  3. NCT03493451

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Anaplastic Large Cell Lymphoma Clinical Trial

Official title:
A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Clinical Trial Summary

This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: - Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) - Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) - Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • ALK-negative Anaplastic Large Cell Lymphoma
  • ALK-Positive Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • Anaplastic Large Cell Lymphoma, ALK-Positive
  • Angioimmunoblastic T-cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma Recurrent
  • Angioimmunoblastic T-Cell Lymphoma Refractory
  • Cutaneous T-cell Lymphoma
  • Extranodal NK T Cell Lymphoma
  • Extranodal NK T Cell Lymphoma, Nasal
  • Extranodal NK/T-cell Lymphoma
  • Extranodal NK/T-cell Lymphoma, Nasal Type
  • Lymphoma
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Neoplasms
  • Peripheral T Cell Lymphoma
  • Peripheral T-cell Lymphoma NOS
  • Peripheral T-Cell Lymphoma Refractory
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • PTCL
Clinical Trial Details
NCT number NCT03493451
Study type Interventional
Source BeiGene
Contact
Status Completed
Phase Phase 2
Start date April 13, 2018
Completion date April 21, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Completed NCT02168140 - CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma Phase 1
Completed NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT01427881 - Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Completed NCT00003196 - Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma N/A
Terminated NCT01678443 - Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies Phase 1
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Terminated NCT01408043 - Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma N/A
Completed NCT01466881 - Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma Phase 2
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00278382 - Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma Phase 2
Completed NCT00131937 - Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma Phase 2
Completed NCT00098891 - MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Completed NCT01254578 - Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers Phase 1
Recruiting NCT03443128 - Vinorelbine for Recurrent ALCL-2017 Phase 2
Completed NCT03397953 - Vinorelbine for Recurrent ACLC Phase 2