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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Xcyte Therapies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xcyte Therapies
ClinicalTrials.gov Identifier:
NCT00081783
First received: April 20, 2004
Last updated: June 23, 2005
Last verified: March 2005
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Xcellerated T Cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Xcyte Therapies:

Estimated Enrollment: 40
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081783

Contacts
Contact: Vicki M. Mizuno 206-262-6251 vmizuno@xcytetherapies.com

Locations
United States, California
California Cancer Care Recruiting
Greenbrae, California, United States, 94904
Contact: Jaime Chang    415-925-5040    JChang@cal-cancer-care.com   
Principal Investigator: Jennifer B. Lucas, MD         
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Lynne Smith    323-865-0371    diansmi@usc.edu   
Principal Investigator: Ann Mohrbacher, MD         
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Cathy Wood    858-939-5062    cathy.wood@sharp.com   
Principal Investigator: Charles Redfern, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Vineeta Prasad    858-822-0337    vprasad@ucsd.edu   
Principal Investigator: Januario E. Castro, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jenny Zhang    415-476-3741    jzhang@medicine.ucsf.edu   
Principal Investigator: Lawrence D. Kaplan, MD         
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy, BS, CCRC    303-285-5087    juli.murphy@usoncology.com   
Principal Investigator: Peter McSweeney, MD         
United States, Georgia
Atlanta Cancer Care Recruiting
Roswell, Georgia, United States, 30342
Contact: Kathy Andrews    404-851-2359    kandrews@atlantacancercare.com   
Principal Investigator: Ronald G. Steis, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: 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
Contact: Natalie Bongiorno, RN, BSN    301-571-0019    nbongiorno@ccbdmd.com   
Principal Investigator: Ralph V. Boccia, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard Boyajian    617-632-3352 ext 42314    Richard_Boyajian@dfci.harvard.edu   
Principal Investigator: Arnold Freedman, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kelly Bryan    314-362-6359    kbryan@im.wustl.edu   
Principal Investigator: Nancy L. Bartlett, MD         
United States, New Jersey
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: John Martin    732-235-8995    martinj4@umdnj.edu   
Principal Investigator: Roger K. Strair, MD, PhD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Mary Weiss    614-293-3437    Weiss-3@medctr.osu.edu   
Principal Investigator: Thomas Lin, MD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Aubyn Grant, CCRP    503-494-5074    granta@ohsu.edu   
Principal Investigator: Brandon Hayes-Lattin, MD         
United States, South Carolina
Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Kim Williams, RN    864-241-6251    kimberly.williams@usoncology.com   
Principal Investigator: Joe J. Stephenson, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ana Ayala    713-792-3610    abayala@mdanderson.org   
Principal Investigator: Peter W. McLaughlin, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Toni Oien, CCRC    206-386-2831    toni.oien@swedish.org   
Principal Investigator: Michael S. Milder, MD         
Virginia Mason Recruiting
Seattle, Washington, United States, 98111
Contact: Aimee Perrault-Gray    206-583-6559 ext 61870    Aimee.PerraultGray@vmmc.org   
Principal Investigator: David M. Aboulafia, MD         
Sponsors and Collaborators
Xcyte Therapies
Investigators
Study Chair: Mark W. Frohlich, MD Xcyte Therapies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00081783     History of Changes
Other Study ID Numbers: XT009
Study First Received: April 20, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Xcyte Therapies:
T Cells
Immunotherapy
NHL
Xcellerated T Cells

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014