Recruiting

Phase 2

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

Sponsor:

Xcyte Therapies

Code:

NCT00081783

Conditions

Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xcellerated T Cells

Study Details

Brief 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

Study ID

NCT00081783

Start date

Mar, 2004

Status verified date

Mar, 2005

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Indolent non-Hodgkin's Lymphoma (NHL), with one of the following subtypes according to the REAL Classification: follicular lymphoma, small lymphocytic lymphoma (SLL), extranodal marginal zone B-cell lymphoma (MALT), nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma), splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes) and mantle cell lymphoma. Other subtypes require approval of the Medical Monitor. At least 16 patients with small lymphocytic lymphoma, and no more than eight patients with mantle cell lymphoma will be enrolled.
Stage III or IV disease at any time in the past
Relapsed or refractory disease following most recent treatment. Patients are considered to have refractory disease if their last treatment course did not result in a complete or partial response, or if time to disease progression was six months or less. Patients are considered to have relapsed disease if time to disease progression is more than six months. Patients who have achieved a partial or complete response following most recent therapy must have demonstrated progressive disease.
Patients must have received at least one prior course of systemic therapy for NHL and no more than four prior courses of therapy. Repeat courses of the same therapeutic regimen separated in time by six or more months are considered separate treatment courses, with the exception of single-agent rituximab. Patients with more than four prior courses of therapy may be enrolled at the discretion of the Medical Monitor after discussion with the Investigator.
Radiographically bi-dimensionally measurable disease. Imaging need not be performed within 15 days prior to registration. Prior scans are acceptable provided that there has been no intervening therapy for NHL. Scans will be obtained at baseline, following registration.
Age of at least 18 years
ECOG performance status of 0 to 2
White blood count (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1000/mm3
CD3+ > 1% of total peripheral white blood cell count by flow cytometry
Platelet count > 50,000/mm3
Hemoglobin ³ 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
Serum total bilirubin and alanine aminotransferase (ALT) ≤ 2.0 times the upper limit of normal
Serum creatinine ≤ 2.0 mg/dL
Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of symptomatic allergic reactions to mice or murine (mouse) proteins. Patients with elevated HAMA levels may be enrolled at the discretion of the Medical Monitor after discussion with the Investigator.
Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B and hepatitis C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards)
Women of childbearing potential must have a negative serum pregnancy test. Both men and women agree to use a medically accepted form of contraception from the time of initial screening through completion of the study.
Able to comprehend and provide signed informed consent

Exclusion Criteria:

Evidence of Hodgkin's lymphoma, Burkitt's lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, lymphoplasmacytic lymphoma, hairy cell leukemia, primary central nervous system lymphoma or any other aggressive lymphoma
Any T cell lymphoma
Evidence of primary cutaneous anaplastic large cell lymphoma, Richter's Syndrome, large granular lymphocytosis and Sézary-cell leukemia. Patients with a prior diagnosis of chronic lymphocytic leukemia, as evidenced by absolute peripheral lymphocyte count of greater than 5,000 per mm3 at any time in the past, are not eligible.
Leukemic manifestations of non-Hodgkin's lymphoma. Small lymphocytic lymphoma patients with peripheral lymphocyte count greater than 5,000 per mm3
Receipt of any chemotherapy, monoclonal antibody, investigational or other systemic therapy (except glucocorticoids as noted below) for the treatment of NHL within 2 months prior to registration
Receipt of glucocorticoids (with the exception of inhaled glucocorticoids) within 1 month prior to registration
Receipt of intravenous immunoglobulin (IVIG) within 1 month of registration
Registration for, or plans to participate in, any other clinical trial of an investigational agent concurrently with this trial
History of malignancy other than NHL within five years of registration, except adequately treated basal or squamous cell skin cancer or in situ carcinoma of the cervix. Other exceptions must be approved by the Xcyte Therapies' Medical Monitor prior to registration.
Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration
Active autoimmune disease requiring systemic treatment
Major organ system dysfunction including (but not limited to): New York Heart Association Class III or IV, severe pulmonary, renal, hepatic, gastrointestinal, neurologic or psychiatric dysfunction which would impair patient's ability to participate in the trial
Any other pertinent medical or psychological condition which leads the Investigator to believe the study would not be appropriate treatment or in the patient's best interest

Study Design

Enrollment

40 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Xcellerated T Cells

Central Contacts and Locations

Central contacts

Vicki M. Mizuno

206-262-6251 vmizuno@xcytetherapies.com

Locations

California Cancer Care

Recruiting

Greenbrae, California, United States, 94904

Contacts

Jaime Chang

415-925-5040 JChang@cal-cancer-care.com

Principal Investigator:

Jennifer B. Lucas, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Vineeta Prasad

858-822-0337 vprasad@ucsd.edu

Principal Investigator:

Januario E. Castro, MD

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Cathy Wood

858-939-5062 cathy.wood@sharp.com

Principal Investigator:

Charles Redfern, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jenny Zhang

415-476-3741 jzhang@medicine.ucsf.edu

Principal Investigator:

Lawrence D. Kaplan, MD

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Contacts

Juli Murphy, BS, CCRC

303-285-5087 juli.murphy@usoncology.com

Principal Investigator:

Peter McSweeney, MD

Atlanta Cancer Care

Recruiting

Roswell, Georgia, United States, 30342

Contacts

Kathy Andrews

404-851-2359 kandrews@atlantacancercare.com

Principal Investigator:

Ronald G. Steis, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Susan Newton, RN

410-502-7985 meusesu@jhmi.edu

Principal Investigator:

Ian W. Flinn, MD, PhD

Center for Cancer & Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Natalie Bongiorno, RN, BSN

301-571-0019 nbongiorno@ccbdmd.com

Principal Investigator:

Ralph V. Boccia, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Richard Boyajian

617-632-3352 Richard_Boyajian@dfci.harvard.edu

Principal Investigator:

Arnold Freedman, MD

Washington University

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Kelly Bryan

314-362-6359 kbryan@im.wustl.edu

Principal Investigator:

Nancy L. Bartlett, MD

Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

John Martin

732-235-8995 martinj4@umdnj.edu

Principal Investigator:

Roger K. Strair, MD, PhD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Mary Weiss

614-293-3437 Weiss-3@medctr.osu.edu

Principal Investigator:

Thomas Lin, MD

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Aubyn Grant, CCRP

503-494-5074 granta@ohsu.edu

Principal Investigator:

Brandon Hayes-Lattin, MD

Cancer Centers of the Carolinas

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Kim Williams, RN

864-241-6251 kimberly.williams@usoncology.com

Principal Investigator:

Joe J. Stephenson, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ana Ayala

713-792-3610 abayala@mdanderson.org

Principal Investigator:

Peter W. McLaughlin, MD

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Toni Oien, CCRC

206-386-2831 toni.oien@swedish.org

Principal Investigator:

Michael S. Milder, MD

Virginia Mason

Recruiting

Seattle, Washington, United States, 98111

Contacts

Aimee Perrault-Gray

206-583-6559 Aimee.PerraultGray@vmmc.org

Principal Investigator:

David M. Aboulafia, MD

More Information

Sponsor

Xcyte Therapies

Last update posted

Jun 24, 2005

Last verified

Mar, 2005

Keywords

T Cells
Immunotherapy
NHL
Xcellerated T Cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Xcyte Therapies on 2005-06-24.