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Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia

Complete title: Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma with Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor

Research Study Number       2639.00
Principal Investigator       David Maloney, MD, PhD
Phase       I/II

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Research Study Description

This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or does not respond to treatment. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Patients with:

-- * Chronic lymphocytic leukemia (CLL) who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody or who were not eligible for such therapy; patients with fludarabine refractory disease are eligible

-- * Indolent non-Hodgkin lymphoma (NHL) or mantle cell NHL who are beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy; patients who have relapsed following autologous hematopoietic cell transplantation (HCT) are eligible

-- * Aggressive NHL such as diffuse large B-cell lymphoma (DLBCL) who have relapsed or have residual disease following treatment with curative intent; patients should have relapsed following, or not be eligible for high-dose therapy and autologous HCT; patients with chemotherapy refractory disease or marrow involvement or comorbidities precluding successful autologous HCT are eligible

-- * Patients with CD19 expressing, relapsed acute lymphoblastic leukemia (ALL)

--- ** Patients with one of the above diagnoses whose disease state does not qualify but who have prognostic indicators that suggest a high risk of progression of disease may be screened and undergo leukapheresis; enrollment for T cell therapy would require meeting the full disease state eligibility

- Confirmation of diagnosis

- Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen or high likelihood of CD19 expression based on disease histology

- Karnofsky performance status >= 60%

- All patients of childbearing potential must be willing to use a physician approved contraceptive method before, during, and for at least two months after the T cell infusion

- Ability to understand and provide informed consent

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

Patients requiring corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent)

- Active autoimmune disease requiring immunosuppressive therapy

- Serum creatinine > 2.5 mg/dL

- Serum glutamic oxaloacetic transaminase (SGOT) > 5 x upper limit of normal

- Bilirubin > 3.0 mg/dL

- Forced expiratory volume in one second (FEV1) of < 2.0 L

- Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 40%

- Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35%

- Patients who are human immunodeficiency virus (HIV) infected

- Men or women of reproductive ability who are unwilling to use effective contraception or abstinence

- Uncontrolled active infection

Other exclusion criteria may apply.

Research Study Number       2639.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Lymphoma, Burkitt's; Hematologic Malignancies; Leukemia; Lymphoma

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  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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