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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

INCLUSIONS FOR SCREENING AND LEUKAPHERESIS

- Patients with CD19 expressing acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL)

- Ability to understand and provide informed consent

- Not human immunodeficiency virus (HIV) infected

INCLUSIONS FOR CAR-T CELL THERAPY

- Patients with:

-- * 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; patients may be treated following allogeneic hematopoietic cell transplant (HCT)

-- * Indolent 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 or allogeneic 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 may be treated following allogeneic HCT

-- * Patients with CD19 expressing, relapsed ALL

- 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)

EXCLUSIONS FOR CAR-T CELL THERAPY

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

- Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI)

- 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% will be excluded

- 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%

- 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
    
   

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

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Please remember:

  • 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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