Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Xcellerated T Cells

Mark W Frohlich, MD

This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.

15 patients in each study arm will be followed for 6 months.

This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.

Xcellerated T CellsTM in Patients With Multiple Myeloma

A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma

Xcyte Therapies

Lymphoma

Lymphoma, Non-Hodgkin

Lymphatic Diseases

Lymphosarcoma

Immunomodulating Agents

Vicki M. Mizuno

Jaime Chang

Jennifer B. Lucas, MD

Lynne Smith

Ann Mohrbacher, MD

Vineeta Prasad

Januario E. Castro, MD

Cathy Wood

Charles Redfern, MD

Jenny Zhang

Lawrence D. Kaplan, MD

Juli Murphy, BS, CCRC

Peter McSweeney, MD

Kathy Andrews

Ronald G. Steis, MD

Susan Newton, RN

Ian W. Flinn, MD, PhD

Natalie Bongiorno, RN, BSN

Ralph V. Boccia, MD

Richard Boyajian

Arnold Freedman, MD

Kelly Bryan

Nancy L. Bartlett, MD

John Martin

Roger K. Strair, MD, PhD

Mary Weiss

Thomas Lin, MD

Aubyn Grant, CCRP

Brandon Hayes-Lattin, MD

Kim Williams, RN

Joe J. Stephenson, MD

Ana Ayala

Peter W. McLaughlin, MD

Toni Oien, CCRC

Michael S. Milder, MD

Aimee Perrault-Gray

David M. Aboulafia, MD

Mark W. Frohlich, MD

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.

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Xcellerated T CellsTM in Patients With Multiple Myeloma	NCT00078065	Multiple Myelom...	Xcellerated T C...	18 Years - 75 Years	Xcyte Therapies
Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients	NCT00081783	Non-Hodgkin's L...	Xcellerated T C...	18 Years -	Xcyte Therapies
Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients	NCT00081783	Non-Hodgkin's L...	Xcellerated T C...	18 Years -	Xcyte Therapies

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