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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

Stephen J Schuster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center, University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 15408

NCT ID:

NCT01013441

Start Date:

March 2009

Completion Date:

March 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

MD Anderson Cancer Center, University of TexasHouston, Texas  77030
Abramson Cancer Center, University of PennsylvaniaPhiladelphia, Pennsylvania  19104