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Chronic Lymphocytic LeukemiaPhase 1/2NCT00058656

Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) Patients

A Phase 1/2 study testing Infusion of Activated & Expanded Autologous T Cells in people with Chronic Lymphocytic Leukemia, run by Xcyte Therapies at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Infusion of Activated & Expanded Autologous T Cells
How many people
18 participants
Where
4 sitesUnited States
Study dates
Mar 2003to not given
Phase
Phase 1/2
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

  • 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:
  • 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
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  • Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly
  • Massive lymph nodes or clusters (i.e. > 10 cm in longest diameter) or progressive lymphadenopathy
  • 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

Who cannot join

  • 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 carcinoma of the cervix. Other exceptions must be approved by the Xcyte Therapies' Medical Monitor prior to registration.
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Atlanta Cancer Care

    Roswell, Georgia, 30076

  • University of California, San Diego

    San Diego, California, 92093-0663

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Infusion of Activated & Expanded Autologous T Cells
Keywords
Immunotherapy, T Cell Therapy, Adoptive immunotherapy, Xcellerate, Xcellerated
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • Infusion of Activated & Expanded Autologous T CellsProcedure or surgery

Timeline

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

  1. First posted10 Apr 2003 (estimated)
  2. Study startMar 2003

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058656
Sponsor's protocol ID
XT004
Status last verified
Jan 2005
First submitted
8 Apr 2003
Last updated
22 Nov 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Infusion of Activated & Expanded Autologous T Cells in people with Chronic Lymphocytic Leukemia, run by Xcyte Therapies at 4 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 16 inclusion and 14 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: finished, as of the sponsor's last update on 22 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058656.

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 22 Nov 2006.

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