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Non-Hodgkin's LymphomaPhase 2NCT00081783

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

A Phase 2 study testing Xcellerated T Cells in people with Non-Hodgkin's Lymphoma, run by Xcyte Therapies at 18 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Xcellerated T Cells
How many people
40 participants
Where
18 sitesUnited States
Study dates
Mar 2004to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

18 sites in 1 country.

Vicki M. Mizuno contact

206-262-6251

vmizuno@xcytetherapies.com

18 sites in 1 country

United States18 sites, 18 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21231

    Susan Newton, RN, 410-502-7985, meusesu@jhmi.edu

    Ian W. Flinn, MD, PhD

    Recruiting

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

    Natalie Bongiorno, RN, BSN, 301-571-0019, nbongiorno@ccbdmd.com

    Ralph V. Boccia, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Richard Boyajian, 617-632-3352 ext. 42314, Richard_Boyajian@dfci.harvard.edu

    Arnold Freedman, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

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

    Thomas Lin, MD

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Juli Murphy, BS, CCRC, 303-285-5087, juli.murphy@usoncology.com

    Peter McSweeney, MD

    Recruiting

  • California Cancer Care

    Greenbrae, California, 94904

    Jaime Chang, 415-925-5040, JChang@cal-cancer-care.com

    Jennifer B. Lucas, MD

    Recruiting

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

    Kim Williams, RN, 864-241-6251, kimberly.williams@usoncology.com

    Joe J. Stephenson, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Ana Ayala, 713-792-3610, abayala@mdanderson.org

    Peter W. McLaughlin, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Lynne Smith, 323-865-0371, diansmi@usc.edu

    Ann Mohrbacher, MD

    Not yet recruiting

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    John Martin, 732-235-8995, martinj4@umdnj.edu

    Roger K. Strair, MD, PhD

    Recruiting

  • Oregon Health Sciences University

    Portland, Oregon, 97239

    Aubyn Grant, CCRP, 503-494-5074, granta@ohsu.edu

    Brandon Hayes-Lattin, MD

    Recruiting

  • Atlanta Cancer Care

    Roswell, Georgia, 30342

    Kathy Andrews, 404-851-2359, kandrews@atlantacancercare.com

    Ronald G. Steis, MD

    Recruiting

  • University of California, San Diego

    San Diego, California, 92093

    Vineeta Prasad, 858-822-0337, vprasad@ucsd.edu

    Januario E. Castro, MD

    Recruiting

  • Sharp Memorial Hospital

    San Diego, California, 92123

    Cathy Wood, 858-939-5062, cathy.wood@sharp.com

    Charles Redfern, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Jenny Zhang, 415-476-3741, jzhang@medicine.ucsf.edu

    Lawrence D. Kaplan, MD

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Toni Oien, CCRC, 206-386-2831, toni.oien@swedish.org

    Michael S. Milder, MD

    Recruiting

  • Virginia Mason

    Seattle, Washington, 98111

    Aimee Perrault-Gray, 206-583-6559 ext. 61870, Aimee.PerraultGray@vmmc.org

    David M. Aboulafia, MD

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Kelly Bryan, 314-362-6359, kbryan@im.wustl.edu

    Nancy L. Bartlett, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Xcellerated T Cells
Keywords
T Cells, Immunotherapy, NHL, Xcellerated T Cells
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xcellerated T CellsDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2004 (estimated)
  2. Study startMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081783
Sponsor's protocol ID
XT009
Status last verified
Mar 2005
First submitted
20 Apr 2004
Last updated
24 Jun 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xcellerated T Cells in people with Non-Hodgkin's Lymphoma, run by Xcyte Therapies at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vicki M. Mizuno (206-262-6251, vmizuno@xcytetherapies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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