Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) Patients
This study is currently recruiting patients.
Sponsored by: |
Xcyte Therapies |
Information provided by: |
Xcyte Therapies |
Purpose
Patients will have immune cells collected and then expanded outside of the body. Patients will receive an infusion of a large
number of expanded immune cells. There will be three dose levels studied. The goal of the study will be to determine the
safety as well as potential efficacy of this treatment.
Condition
|
Treatment or Intervention |
Phase |
Chronic Lymphocytic Leukemia
|
Procedure: Infusion of Activated & Expanded Autologous T Cells
|
Phase I Phase II
|
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of Xcellerated T Cells(tm) in Patients with Chronic Lymphocytic Leukemia (CLL)
Further Study Details:
Expected Total Enrollment:
18
Study start: March 2003
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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 registration
- 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 carcioma 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
Location
and Contact
Information
California University of California, San Diego, San Diego,
California,
92093-0663,
United States; No longer recruiting
Georgia Atlanta Cancer Care, Roswell,
Georgia,
30076,
United States; Not yet recruiting
Maryland Center for Cancer & Blood Disorders, Bethesda,
Maryland,
20817,
United States; Recruiting
Texas MD Anderson Cancer Center, Houston,
Texas,
77030,
United States; No longer recruiting
Study chairs or principal investigators
Mark Frohlich, MD, Study Director, Xcyte Therapies
More Information
Xcyte Therapies home page
Study ID Numbers:
XT004
Record last reviewed:
September 2004
Record first received:
April 8, 2003
ClinicalTrials.gov Identifier:
NCT00058656Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29