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Clinical Trial Summary

The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).


Clinical Trial Description

OUTLINE: This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy. Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide intravenously (IV). Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Patients will be actively participating in the study for approximately 15 months. The total time includes the time for the T cells to be made, the T cell infusion, and for approximately 12 months after the T cell infusion is given. After completion of study treatment, patients are followed up for a minimum of 15 years. ;


Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Recurrence
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Central Nervous System Lymphoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
  • Recurrent Transformed Chronic Lymphocytic Leukemia
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Central Nervous System Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • Refractory Transformed B-Cell Non-Hodgkin Lymphoma
  • Refractory Transformed Chronic Lymphocytic Leukemia
  • Refractory Transformed Non-Hodgkin Lymphoma
  • Waldenstrom Macroglobulinemia

NCT number NCT03277729
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date December 5, 2017
Completion date November 16, 2037

See also
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