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

November 20, 2006 updated by: Xcyte Therapies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093-0663
        • University of California, San Diego
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Atlanta Cancer Care
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xcyte Therapies

Investigators

  • Study Director: Mark Frohlich, MD, Xcyte Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Registration Dates

First Submitted

April 8, 2003

First Submitted That Met QC Criteria

April 9, 2003

First Posted (Estimate)

April 10, 2003

Study Record Updates

Last Update Posted (Estimate)

November 22, 2006

Last Update Submitted That Met QC Criteria

November 20, 2006

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XT004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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