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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark W. Frohlich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Xcyte Therapies

Authority:

United States: Food and Drug Administration

Study ID:

XT009

NCT ID:

NCT00081783

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • T Cells
  • Immunotherapy
  • NHL
  • Xcellerated T Cells
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
MD Anderson Cancer CenterHouston, Texas  77030-4096
Swedish Cancer InstituteSeattle, Washington  98104
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Rocky Mountain Cancer CentersThornton, Colorado  80260
Sharp Memorial HospitalSan Diego, California  92123
University of California, San FranciscoSan Francisco, California  94143
Atlanta Cancer CareAtlanta, Georgia  30342
Oregon Health Sciences UniversityPortland, Oregon  
Ohio State UniversityColumbus, Ohio  43210
Washington UniversitySt. Louis, Missouri  63110
University of California, San DiegoLa Jolla, California  92037-1709
California Cancer CareGreenbrae, California  94904
Center for Cancer & Blood DisordersBethesda, Maryland  20817
University of Southern CaliforniaLos Angeles, California  90033
Virginia MasonSeattle, Washington  98111