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A Phase I/II Study of Xcellerated T Cells(tm) in Patients With Chronic Lymphocytic Leukemia (CLL)

Phase 1/Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

A Phase I/II Study of Xcellerated T Cells(tm) in Patients With Chronic Lymphocytic Leukemia (CLL)

This is a Phase I/II single arm dose escalation study of a novel T cell immunotherapy for
chronic lymphocytic leukemia (CLL). Patients will receive one dose of Xcellerated T
Cells(tm), an ex vivo activated and expanded autologous T cell product, in an attempt to
enhance immune responses with anti-tumor activity. This study is being conducted to test
the safety and determine the maximum tolerated dose (MTD) of Xcellerated T Cells in patients
with CLL. In addition, lymphocyte counts, lymph node area, and quantitative immunoglobulins
will be assessed for preliminary evidence of a therapeutic effect. In correlative studies,
changes in the phenotype of T and B lymphocytes will be evaluated by flow cytometry. Changes
in T cell repertoire and anti-tumor immune activity will also be assessed. It is expected
that 12 to 18 patients will be treated.

Inclusion Criteria

Inclusion criteria:

- Diagnosis of CLL at any time in the past, as defined by all of the following:

> 5 x 109 peripheral blood lymphocytes/L which are positive for CD5 and one or more B cell
markers (CD19, CD20, CD23).

< 55% of lymphocytes identified as prolymphocytes

- Intermediate or High Risk disease as defined by the Modified 3-stage system

- Patients with Intermediate Risk (Rai Stages I and II) must have active disease, as
determined by one or more of the following criteria:

1. One or more of the following disease related symptoms i. Weight loss > 10%
within the previous 6 months ii. Fevers of greater than 100.5°F for > 2 weeks
iii. Night sweats without evidence of infection

2. Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly

3. Massive lymph nodes or clusters (i.e. > 10 cm in longest diameter) or
progressive lymphadenopathy

4. Progressive lymphocytosis with an increase of >50% over a 2-month period, or an
anticipated doubling time of less than 12 months

- T cells (CD3+) comprising > 1.5% and < 10 % of peripheral white blood cells as
assessed by flow cytometry

- CD4+/CD8+ of > 0.30, as assessed by flow cytometry

- Age of at least 18 years

- ECOG performance status of 0 to 2

- Life expectancy 6 months

- Able to comprehend and provide signed informed consent

- Women of childbearing potential must have a negative serum pregnancy test and agree
to use a medically accepted form of contraception from the time of initial screening
through completion of the study

Exclusion Criteria

- Evidence of Richter’s Syndrome, T cell CLL, prolymphocytic leukemia, hairy-cell
leukemia, splenic lymphoma with villous lymphocytes, large granular lymphocytosis,
Sezary-cell leukemia, adult T-cell leukemia/lymphoma, or leukemic manifestations of
non-Hodgkin’s lymphoma

- Receipt of any chemotherapy, monoclonal antibody, investigational, or other systemic
therapy for the treatment of CLL within 2 months prior to registration.

- Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for
the use of allergic rhinitis or pulmonary disease) within 2 months prior to

- Receipt of intravenous immunoglobulin (IVIG) within 1 month of registration

- Registration for, or plans to participate in, any other clinical trial concurrently
for the duration of this trial

- History of malignancy other than CLL 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

- Liver disease or hepatitis as reflected by a serum bilirubin or ALT > 2.0 times the
upper limit of normal laboratory range within 15 days of registration

- Compromised renal function as reflected by a serum creatinine > 2 times the upper
limit of normal laboratory range within 15 days of registration

- History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple
sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is
permitted if treatment with steroids has not been required in the two months prior to
registration. Hypothyroidism without evidence of Grave’s Disease or Hashimoto’s
thyroiditis is permitted.

- Major organ system dysfunction including (but not limited to): New York Heart
Association Class III or IV (Appendix B, page 51), pulmonary disease requiring the
use of inhaled steroids or bronchodilators, renal, hepatic, gastrointestinal,
neurologic, or psychiatric dysfunction which would impair patient’s ability to
participate in the trial

- Evidence of infection with HIV 1 or 2, HTLV 1 or 2

- Evidence of acute or active chronic Hepatitis B or C infection

- Positive human anti-mouse antibody (HAMA) test as performed at the central reference
laboratory designated by the sponsor

Type of Study:


Study Design:

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

Principal Investigator

Mark Frohlich, MD

Investigator Role:

Study Director

Investigator Affiliation:

Xcyte Therapies


United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Immunotherapy
  • T Cell Therapy
  • Adoptive immunotherapy
  • Xcellerate
  • Xcellerated
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



MD Anderson Cancer Center Houston, Texas  77030-4096
Atlanta Cancer Care Atlanta, Georgia  30342
University of California, San Diego La Jolla, California  92037-1709
Center for Cancer & Blood Disorders Bethesda, Maryland  20817