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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:March 2004
Contact:Vicki M. Mizuno
Email:vmizuno@xcytetherapies.com
Phone:206-262-6251

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

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.


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
We found this trial at
18
sites
Roswell, Georgia 30342
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Denver, Colorado 80218
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Denver, CO
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Greenbrae, California 94904
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Greenbrae, CA
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Greenville, South Carolina 29605
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Greenville, SC
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Houston, Texas 77030
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Houston, TX
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New Brunswick, New Jersey 08901
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Portland, Oregon 97227
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San Diego, California 92093
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Francisco, California 94143
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Seattle, Washington 98104
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Seattle, Washington 98111
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