CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01013441
• Collaborator: M.D. Anderson Cancer Center (Other)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Duration (Months): 117
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Biological: Infusion of CD3/CD28 stimulated T cells	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm	Biological: Infusion of CD3/CD28 stimulated T cells; Receive CD3/CD28 stimulated T cells after fludarabine or alemtuzumab based chemotherapy; Other Names: Activated T cells CD3/CD28 stimulated T cells T cells

Outcome Measures

Primary Outcome Measures

1. 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 [Two years]

2. The ability to complete the outlined course of therapy [Two years]

3. The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients [Two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	MD Anderson Cancer Center, University of Texas	Houston	Texas	United States	77030

Sponsors and Collaborators

• University of Pennsylvania
• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Stephen J Schuster, MD, Abramson Cancer Center, University of Pennsylvania
• Principal Investigator: Chitra Hosing, MD, MD Anderson Cancer Center University of Texas

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center
• Abramson Cancer Center

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01013441
• Other Study ID Numbers: UPCC 15408; NCT00870090
• First Posted: Nov 13, 2009
• Last Update Posted: Oct 23, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of Pennsylvania: Chronic Lymphocytic Leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Oct 23, 2019