Back to resultsCD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Infusion of CD3/CD28 stimulated T cells
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
- Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
- Zubrod performance status of 0-3
- Prior treatment with fludarabine or alemtuzumab based regimens.
- No untreated or uncontrolled life-threatening infection
- 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
- No active CNS disease
- Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.
Exclusion Criteria:
- 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
- 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 not requiring active treatment
Sites / Locations
- Abramson Cancer Center, University of Pennsylvania
- MD Anderson Cancer Center, University of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Outcomes
Primary Outcome Measures
The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time
The ability to complete the outlined course of therapy
The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients
Secondary Outcome Measures
Full Information
NCT ID
NCT01013441
First Posted
November 5, 2009
Last Updated
October 21, 2019
Sponsor
University of Pennsylvania
Collaborators
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01013441
Brief Title
CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
Official Title
Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).
Detailed Description
Single arm, multi-center trial to evaluate the efficacy of administering CD3/CD28 stimulated T cells to chronic lymphocytic leukemia (CLL) patients following treatment with fludarabine or alemtuzumab based chemo- immunotherapy. All patients will undergo an apheresis to collect peripheral blood mononuclear cells (PBMCs) for generation of expanded T cells post- chemo-immunotherapy. Those subjects who achieve a complete or partial response to the chemoimmunotherapy based regimen will receive an infusion of 1.0 x 1010 (+/- 20%) activated autologous T cells expanded from the collected apheresis unit. Prior to T-cell infusion, at Day +30, +60, and +365 after T cell infusion, blood draws will be performed to assess immune reconstitution and immune function as compared to baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Infusion of CD3/CD28 stimulated T cells
Other Intervention Name(s)
Activated T cells, CD3/CD28 stimulated T cells, T cells
Intervention Description
Receive CD3/CD28 stimulated T cells after fludarabine or alemtuzumab based chemotherapy
Primary Outcome Measure Information:
Title
The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time
Time Frame
Two years
Title
The ability to complete the outlined course of therapy
Time Frame
Two years
Title
The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
Zubrod performance status of 0-3
Prior treatment with fludarabine or alemtuzumab based regimens.
No untreated or uncontrolled life-threatening infection
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
No active CNS disease
Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.
Exclusion Criteria:
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
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 not requiring active treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Schuster, MD
Organizational Affiliation
Abramson Cancer Center, University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chitra Hosing, MD
Organizational Affiliation
MD Anderson Cancer Center University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
MD Anderson Cancer Center, University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org/
Description
MD Anderson Cancer Center
URL
http://www.penncancer.org/
Description
Abramson Cancer Center
Learn more about this trial
CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
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