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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|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
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)
- 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.
Burkitt's Lymphoma; Hematologic Malignancies; Leukemia; Lymphoma
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