Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00081783

Recruitment Status:

Unknown status

Sponsor:

Xcyte Therapies

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There are 18 Locations for this study

See Locations Near You

California Cancer Care
Greenbrae California, 94904, United States More Info
Jaime Chang
Contact
415-925-5040
[email protected]
Jennifer B. Lucas, MD
Principal Investigator
University of Southern California
Los Angeles California, 90033, United States More Info
Lynne Smith
Contact
323-865-0371
[email protected]
Ann Mohrbacher, MD
Principal Investigator
University of California, San Diego
San Diego California, 92093, United States More Info
Vineeta Prasad
Contact
858-822-0337
[email protected]
Januario E. Castro, MD
Principal Investigator
Sharp Memorial Hospital
San Diego California, 92123, United States More Info
Cathy Wood
Contact
858-939-5062
[email protected]
Charles Redfern, MD
Principal Investigator
University of California, San Francisco
San Francisco California, 94143, United States More Info
Jenny Zhang
Contact
415-476-3741
[email protected]
Lawrence D. Kaplan, MD
Principal Investigator
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States More Info
Juli Murphy, BS, CCRC
Contact
303-285-5087
[email protected]
Peter McSweeney, MD
Principal Investigator
Atlanta Cancer Care
Roswell Georgia, 30342, United States More Info
Kathy Andrews
Contact
404-851-2359
[email protected]
Ronald G. Steis, MD
Principal Investigator
Johns Hopkins University
Baltimore Maryland, 21231, United States More Info
Susan Newton, RN
Contact
410-502-7985
[email protected]
Ian W. Flinn, MD, PhD
Principal Investigator
Center for Cancer & Blood Disorders
Bethesda Maryland, 20817, United States More Info
Natalie Bongiorno, RN, BSN
Contact
301-571-0019
[email protected]
Ralph V. Boccia, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Richard Boyajian
Contact
617-632-3352
[email protected]
Arnold Freedman, MD
Principal Investigator
Washington University
St. Louis Missouri, 63110, United States More Info
Kelly Bryan
Contact
314-362-6359
[email protected]
Nancy L. Bartlett, MD
Principal Investigator
Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
John Martin
Contact
732-235-8995
[email protected]
Roger K. Strair, MD, PhD
Principal Investigator
Ohio State University
Columbus Ohio, 43210, United States More Info
Mary Weiss
Contact
614-293-3437
[email protected]
Thomas Lin, MD
Principal Investigator
Oregon Health Sciences University
Portland Oregon, 97239, United States More Info
Aubyn Grant, CCRP
Contact
503-494-5074
[email protected]
Brandon Hayes-Lattin, MD
Principal Investigator
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States More Info
Kim Williams, RN
Contact
864-241-6251
[email protected]
Joe J. Stephenson, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ana Ayala
Contact
713-792-3610
[email protected]
Peter W. McLaughlin, MD
Principal Investigator
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Toni Oien, CCRC
Contact
206-386-2831
[email protected]
Michael S. Milder, MD
Principal Investigator
Virginia Mason
Seattle Washington, 98111, United States More Info
Aimee Perrault-Gray
Contact
206-583-6559
[email protected]
David M. Aboulafia, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT00081783

Recruitment Status:

Unknown status

Sponsor:


Xcyte Therapies

How clear is this clinincal trial information?

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