NCT00081783

Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients

A Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Xcyte Therapies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent non-Hodgkin's lymphoma (NHL). Eligible patients will have relapsed or refractory disease after receiving at least one and no more than four prior regimens. Patients will receive Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL. Secondary endpoints are to evaluate the safety of the therapy in this patient population, and to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be evaluated in patients amenable to biopsy of enlarged lymph nodes.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Xcellerated T Cells

Timeline

• Start date: 2004-03-01
• First posted: 2004-04-22
• Last updated: 2005-06-24

Locations

18 sites across 1 country: United States